MRx Pipeline October 2023 by Prime/Magellan Rx

MR x PIPELINE MRx AAVIEW & TRADITIONAL TRADITIONALDRUGS DRUGS VIEWINTO INTO UPCOMING UPCOMING SPECIALTY SPECIALTY &

OCTOBER JANUARY2023 2022

Table of CONTENTS

EDITORIAL STAFF Maryam Tabatabai, PharmD Editor-in-Chief Vice President, Clinical Information

EDITOR-IN-CHIEF'S MESSAGE

Carole Kerzic, RPh Executive Editor Clinical Pharmacist, Drug Information

PIPELINE DEEP DIVE

Consultant Panel

KEEP ON YOUR RADAR

Katie Lockhart Senior Manager, Forecasting and Pharmacoeconomics

PIPELINE DRUG LIST

GLOSSARY

Robert Greer, RPh, BCOP Vice President, Clinical Strategy and Programs

Olivia Pane, PharmD, CDCES Clinical Pharmacist, Drug Information Michelle Pannone-Booth, PharmD Director, Specialty Clinical Solutions Katherine E. Rebello, PharmD Clinical Project Manager Nothing herein is or shall be construed as a promise or representation regarding past or future events and Magellan Rx Management expressly disclaims any and all liability relating to the use of or reliance on the information contained in this presentation. The information contained in this publication is intended for educational purposes only and should not be considered clinical, financial, or legal advice. By receipt of this publication, each recipient agrees that the information contained herein will be kept confidential and that the information will not be photocopied, reproduced, distributed to, or disclosed to others at any time without the prior written consent of Magellan Rx Management.

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Editor-in-Chief's MESSAGE Welcome to the MRx Pipeline. This quarterly publication offers clinical insights and competitive intelligence on anticipated drugs in development, so you are well-sourced on the drug pipeline. MRx Pipeline, our universal forecast, addresses trends applicable across market segments. Traditional and specialty drugs as well as agents under the pharmacy and medical benefits are featured. Also profiled in the report are new molecular entities, pertinent new and expanded indications for existing medications, and biosimilars. Clinical analyses, financial outlook, and pre-regulatory status are considered. The products housed in the MRx Pipeline have been researched in detail. They have been developed in consultation with our internal team of clinical and analytics experts.

METHODOLOGY

Emerging therapeutics continue to grow and influence the clinical and financial landscape. Therefore, Magellan Rx Management has developed a systematic approach to determine the products with significant clinical impact. For the in-depth clinical evaluations, the products’ potential to meet an underserved need in the market by becoming the new standard of care, and the ability to replace existing therapies were investigated. The extent to which the pipeline drugs could shift market share on a formulary and their impact on disease prevalence were also important considerations. In order to assist payers with assessing the potential impact of these pipeline drugs, where available, a financial forecast has been included for select products. Primarily complemented by data from EvaluateTM, this pipeline report looks ahead at the 5-year projected annual US sales through the year 2027. These figures are not specific to a particular commercial or government line of business; rather, they look at forecasted total US sales. Depending on a variety of factors, including the therapeutic categories, eventual FDA-approved indications, populations within the plan, and other indices, the financial impact could vary by different lines of business.

REFLECTION

Thus far in 2023, the FDA has approved 43 novel drugs, compared to only 28 about the same time last year. For the remainder of the year, 24 notable drugs filed with the agency are profiled, each with an anticipated FDA decision in 2023. While numbers do not tell the entire story, they do represent significant innovation in patient care and advance public health for the American public.

ON THE HORIZON

As we look ahead, there is a continued trend towards the approval of specialty medications and drugs for rare conditions, with 69% and 34% of approvals expected, respectively, for agents with applications submitted to the FDA. There are 2 agents seeking FDA’s Accelerated Approval, which allows for earlier drug approval for serious conditions that fill an unmet need based on a surrogate endpoint reasonably likely to predict a clinical benefit. A new dual-acting option for obesity, the first ever treatment for NASH, new oral options for DMD and schizophrenia, a topical formulation for molluscum contagiousum, and a once-weekly insulin are expected. Approval of 2 new gene therapies for hemophilia A and B and a self-administered intranasal flu vaccine are on the horizon. Moreover, sprouting products for cardiology and Alzheimer's disease are being actively monitored through MRx Pipeline. Other noteworthy pipeline trends to watch include the development of complex therapies, cell and gene therapies “CGT,” oncology, immunology, and therapeutic options for ultra-rare hereditary diseases. The drug pipeline ecosphere will continue to evolve as it faces challenges and successes. Innovative agents that show positive results without compromising patient safety and access offer true therapeutic advances and hold the promise to alter the treatment paradigm. Maryam Tabatabai, PharmD Editor-in-Chief, MRx Pipeline

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Pipeline DEEP DIVE Objective evidence-based methodology was used to identify the Deep Dive drugs in the upcoming quarters. This section features a clinical overview and explores the potential place in therapy for these agents. Moreover, it addresses their FDA approval timeline and 5-year financial forecast.

SPECIALTY

PRIORITY REVIEW

BREAKTHROUGH THERAPY

83%

14%

BIOSIMILAR

ORPHAN DRUG

69%

14%

pecialty drug names appear in  S magenta throughout the publication.

CARDIOLOGY

aprocitentan oral Idorsia PROPOSED INDICATIONS Resistant hypertension

CLINICAL OVERVIEW

Aprocitentan is a dual endothelin receptor antagonist. The 3-part, phase 3 PRECISION trial (NCT03541174) evaluated aprocitentan in 730 adults with a sitting SBP ≥ 140 mm Hg despite standard background therapy (3 antihypertensive agents, including a diuretic). Many patients enrolled had comorbidities including diabetes, CKD, obesity, and congestive HF. In part 1 (double-blind), patients were randomized 1:1:1 to once daily aprocitentan 12.5 mg, aprocitentan 25 mg, or placebo for 4 weeks. A significant reduction in the primary endpoint of LS mean change in office SBP at week 4 was demonstrated with aprocitentan 12.5 mg and 25 mg compared to placebo (placebo-adjusted change, -3.8 mm Hg and -3.7 mm Hg, respectively; p<0.005 for both). A reduction in office DBP was also seen with each dose compared to placebo (placebo-adjusted change, -3.9 mm Hg and -4.5 mm Hg, respectively). In part 2 (patient-blinded), all patients received aprocitentan 25 mg (n=704) and the SBP and DBP reductions seen with aprocitentan were maintained for 32 weeks. In part 3 (double-blind), patients were re-randomized 1:1 to continue aprocitentan 25 mg or switch to placebo (withdrawal) for 12 weeks. Among patients who were switched to placebo, the office SBP and DBP increased significantly (5.8 mm Hg and 5.2 mm Hg, respectively; p<0.001 for both) after 4 weeks compared to those who continued aprocitentan. Dose-dependent mild to moderate fluid retention was reported with aprocitentan.

PLACE IN THERAPY

According to a 2018 AHA Scientific Statement, an estimated 10.3 million (19.7%) adults in the U.S. have apparent resistant hypertension, defined as failure to achieve target BP (130/80 mm Hg) despite treatment with 3 antihypertensive medications with complementary mechanisms of action, with 1 being a diuretic, or when a patient requires ≥ 4 medications to achieve the desired BP. Patients with resistant hypertension are at increased risk of CHD, stroke, PAD, HF, ESRD, and all-cause mortality. Resistant hypertension is more likely to affect Blacks or African Americans and individuals with advanced age, obesity, CKD or diabetes. Lifestyle intervention (e.g., weight loss, sodium restriction, exercise) and addressing causes of secondary hypertension are important for managing hypertension. Empirical pharmacotherapy combines medications with complementary mechanisms and includes a diuretic, a calcium channel blocker, and a renin-angiotensinaldosterone system blocker (ACEI or ARB). If BP goals are not met with 3 antihypertensive agents, stepwise additions of the following agents are made: mineralocorticoid receptor antagonist, beta-blocker and hydralazine. The endothelin-1 (ET-1) peptide, produced by endothelial cells, is a potent vasoconstrictor and contributes to the regulation of sodium and water in the kidneys. ET-1 expression is amplified in patients with severe hypertension and is involved in BP elevation and vascular hypertrophy. Aprocitentan inhibits the binding of ET-1 to the ETA and ETB receptors. In clinical trials, significant changes in BP were observed within 14 days of starting aprocitentan. If approved, aprocitentan will be the first dual endothelin receptor antagonist to treat resistant hypertension, a condition that is lacking therapeutic options. Notably, aprocitentan has not been evaluated for its effect on CV outcomes. In addition, aprocitentan is an active metabolite of macitentan (Opsumit®) that is indicated in patients with PAH. Macitentan carries a boxed warning for embryo-fetal toxicity; it remains to be seen if aprocitentan will carry this warning.

FDA APPROVAL TIMELINE December 19, 2023

FINANCIAL FORECAST (reported in millions) Year

2023

2024

2025

2026

2027

Projected Total U.S. Sales

$11

$28

$52

$74

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INFECTIOUS DISEASE

berdazimer topical Ligand PROPOSED INDICATIONS Molluscum contagiosum (MC)

CLINICAL OVERVIEW

Berdazimer is a topical nitric oxide-releasing antiviral. The randomized, double-blind, vehicle-controlled, phase 3 B-SIMPLE4 trial (NCT04535531) evaluated berdazimer 10.3% gel in 891 immunocompetent patients ≥ 6 months of age with MC that was not sexually transmitted or in the periocular area. The study revealed significantly more patients treated with berdazimer achieved the primary endpoint of complete clearance of all MC lesions at week 12 compared to patients who received vehicle (43.5% versus 24.6%, respectively; p<0.001). A significant difference between the groups was observed as early as week 4. Notably, in the randomized, double-blind, phase 3 B-SIMPLE1 (NCT03927716; n=352) and B-SIMPLE2 (NCT03927703; n=355) trials in patients ≥ 6 months of age with MC, berdazimer did not demonstrate a statistically significant difference from vehicle in the primary endpoint of complete clearance of treatable MC lesions at week 12 (B-SIMPLE1, 25.8% versus 21.6%, respectively [p=0.375]; B-SIMPLE2, 30% versus 20.3%, respectively [p=0.062]). In all 3 trials, berdazimer was well tolerated. The most common TEAEs were application site pain and erythema. Most were mild in severity. Berdazimer 10.3% gel was administered topically by the patient or caregiver once daily as a thin layer to the top of all MC lesions identified at baseline and any new lesions that arose, for a maximum of 12 weeks.

PLACE IN THERAPY

MC is a highly contagious viral skin infection caused by molluscipoxvirus that affects an estimated 6 million people in the U.S. annually. Small, raised, pus-filled lesions 2 to 5 mm in size appear throughout the body (except hands and feet) and may itch or be tender. MC is transmitted by direct contact with lesions or contaminated clothing, linen, sports equipment and toys. MC is most commonly seen in children 1 to 14 years of age and in people with weakened immune systems (e.g., HIV-1-positive). MC is particularly reported in crowded, warm, humid conditions. MC lesions typically resolve within 6 to 12 months, but may take as long as 4 to 5 years to clear if left untreated. Reasons to treat MC include: immunocompromised status, genital MC lesions, underlying atopic condition, transmission or autoinoculation prevention, scarring prevention, and elimination of social stigma. Cryotherapy, curettage and laser therapy have been used by HCPs to remove MC lesions. In July 2023, cantharidin 0.7% topical solution (Ycanth™) became the first FDA-approved medication to treat MC. The topical blistering agent is indicated for use in patients ≥ 2 years of age and is administered by a trained HCP every 3 weeks, as needed, for up to 4 treatments. Other agents that have been used off-label include oral cimetidine and the topical products podophyllotoxin, imiquimod (not recommended in children), retinoids, salicylic acid, iodine and potassium hydroxide. Treatment of MC in immunocompromised patients (e.g., HIV-1-positive) may be a challenge, and immune boosting therapies have been shown to be effective. If approved, berdazimer will be a first-in-class, nitric oxide-releasing antiviral treatment for MC. It will also be the first FDA-approved agent for topical home-administration and may be a more convenient alternative to HCP-administered cantharidin (Ycanth). In non-comparative trials, the percentage of patients who experienced complete clearance of MC lesions was 43.5% with berdazimer (B-SIMPLE-4) and 46% to 54% with cantharidin. The phase 3 studies for both products did not include immunocompromised patients.

FDA APPROVAL TIMELINE January 5, 2024

FINANCIAL FORECAST (reported in millions) Year

2023

2024

2025

2026

2027

Projected Total U.S. Sales

$47

$109

$179

$237

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NEUROLOGY

eplontersen SC Ionis/AstraZeneca PROPOSED INDICATIONS

Hereditary transthyretin-mediated amyloid polyneuropathy (hATTRv-PN)

CLINICAL OVERVIEW

Eplontersen is a ligand-conjugated antisense (LICA) agent that inhibits the production of the transthyretin (TTR) protein. Eplontersen shares the same nucleotide sequence as inotersen that is FDA-approved for ATTRv-PN. The open-label, phase 3 NEURO-TTRansform study evaluated eplontersen in 144 adults with hATTRv-PN who could ambulate independently or with support. Eplontersen treatment demonstrated significant benefit in 3 co-primary endpoints at 66 weeks compared to data from an external placebo group. This included a reduction from baseline in serum TTR concentration (LS mean reduction, 81.7% versus 11.2%, respectively [p<0.0001]); halting of disease progression based on the modified Neuropathy Impairment Score +7 (mNIS+7) (LS mean increase, 0.3 versus 25.1, respectively [p<0.0001]); and improved QOL based on the Norfolk QOL Questionnaire-Diabetic Neuropathy (Norfolk QOL-DN) score (LS mean change, -5.5 versus +14.2, respectively [p<0.0001]). Among patients treated with eplontersen in the overall study population, 47% showed neuropathy improvement and 58% reported QOL improvement compared to 17% and 20%, respectively, in the external placebo group. Benefits from eplontersen were seen as early as 35 weeks and were maintained at 85 weeks. Eplontersen was well tolerated, with TEAEs comparable to the external placebo group. Two deaths occurred in the eplontersen group due to hATTR-PN amyloidosis sequelae. Eplontersen was administered SC at a dose of 45 mg once every 4 weeks.

PLACE IN THERAPY

ATTRv-PN is a rare, progressive, fatal neurodegenerative condition caused by mutations in the TTR gene. It is characterized by accumulation of abnormal amyloid proteins in organs and tissues that lead to sensory and motor polyneuropathy. In the U.S., an estimated 1 in 100,000 individuals are affected by hATTR amyloidosis. Symptoms usually become evident between 20 and 50 years of age. Peripheral sensorimotor nerves and nerves of the upper and lower limbs may be affected in a symmetric manner. CNS involvement may be observed in advanced stages. If left untreated, death occurs within 7 to 12 years after diagnosis. The TTR proteins are primarily produced in the liver. Prior to the approval of the TTR-directed antisense agents, which are inotersen (Tegsedi®; 2018), patisiran (Onpattro®; 2018), and vutrisiran (Amvuttra®; 2022), liver transplantation was the only DMT available for hATTRv-PN. If approved, eplontersen will be the fourth TTR-targeting treatment available in the U.S. for hATTRv-PN. In the clinical trial, it was well tolerated and was shown to halt progression of neuropathy, reduce TTR protein concentrations, and improve QOL. If approved, eplontersen may provide a convenient every-4-week selfadministered option. In comparison, inotersen is self-administered as weekly SC injections, and vutrisiran and patisiran are HCP-administered as an every-3-month SC injection and every-3-week IV infusion, respectively. Moreover, while inotersen carries boxed warnings for thrombocytopenia and glomerulonephritis and is available only through a REMS program, these TEAEs have not been reported with eplontersen.

FDA APPROVAL TIMELINE December 22, 2023  Orphan Drug

FINANCIAL FORECAST (reported in millions) Year

2023

2024

2025

2026

2027

Projected Total U.S. Sales

$39

$85

$189

$261

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RESPIRATORY

gefapixant oral Merck PROPOSED INDICATIONS Chronic cough

CLINICAL OVERVIEW

Gefapixant is an oral selective antagonist of the P2X3 receptor that is found on sensory nerve fibers in the lining of the airway. The randomized, double-blind, placebo-controlled phase 3 COUGH-1 (NCT03449134) and COUGH-2 (NCT03449147) trials evaluated gefapixant in a total of 2,044 adults with refractory chronic cough or unexplained chronic cough for a mean duration of 11 years. Gefapixant 45 mg demonstrated a statistically significant reduction in 24-hour cough frequency (primary endpoint) compared to placebo at week 12 in COUGH-1 (reduction relative to placebo, 18.45%; p=0.041), and at week 24 in COUGH-2 (reduction relative to placebo, 14.64%; p=0.031). A clinically important level of improvement in QOL as related to cough was reported by 77.1% of patients who received gefapixant 45 mg. A gefapixant 15 mg twice daily dose was also evaluated in the studies but did not demonstrate a significant benefit compared to placebo. Gefapixant was associated with taste disturbances. In COUGH-1 and COUGH-2, 15% and 20% of patients treated with gefapixant 45 mg, respectively, discontinued the trial due to TEAEs. Gefapixant 45 mg was administered orally twice daily.

PLACE IN THERAPY

Chronic cough is defined as cough lasting > 8 weeks. Chronic cough is considered either refractory chronic cough when it does not respond to treatment of underlying conditions (e.g., asthma or GERD), or unexplained chronic cough when there is no identifiable underlying condition. Patients may have a heightened cough reflex that is triggered by low levels of thermal, chemical or mechanical stimuli. Chronic cough of this type is usually dry or minimally productive. Patients often report musculoskeletal chest pains, sleep disturbance and hoarse voice. In addition, blackouts, stress incontinence and vomiting can occur in more serious cases. It is estimated that chronic cough affects 5% to 10% of adults and is more common among females and people in their 50s and 60s. Chronic cough that is secondary to upper and lower airway conditions (e.g., COPD, asthma, allergies, rhinitis), GERD, obstructive sleep apnea, medications or smoking may resolve when the underlying cause has been identified and treated. In general, adequate fluid intake, air humidification, avoidance of irritants, and OTC antitussive agents may provide cough relief. However, treatments for unexplained or refractory chronic cough are lacking. The American College of Chest Physicians (CHEST) suggests a therapeutic trial of multimodality speech pathology therapy for unexplained chronic cough. Gabapentin may be tried after review of risks and benefits of therapy with the patient. Extracellular adenosine triphosphate (ATP) plays a key role in airway inflammation and has become a potential target for treating refractory chronic cough. Upon airway inflammation, irritation or mechanical stress/injury, cells lining the airway release ATP. Extracellular ATP then binds to and activates P2X3 receptors on vagal afferent nerves of the airway and induces the cough reflex. Gefapixant is a first-in-class P2X3 receptor antagonist that has demonstrated 15% to 18% reduction in cough frequency (relative to placebo) through reduction of sensory nerve activation in patients with refractory or unexplained chronic cough. In studies, gefapixant has been associated with taste disturbances. If approved, it will be the first medication in the U.S. indicated specifically for refractory or unexplained chronic cough.

FDA APPROVAL TIMELINE

December 27, 2023 (An FDA advisory committee review is planned for November 17, 2023.)

FINANCIAL FORECAST (reported in millions) The projected total U.S. sales for gefapixant are not available.

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MUSCULOSKELETAL

givinostat oral Italfarmaco PROPOSED INDICATIONS

Duchenne muscular dystrophy (DMD)

CLINICAL OVERVIEW

Givinostat is a histone deacetylases (HDACs) inhibitor. The multinational, double-blind, placebo-controlled, phase 3 EPIDYS (NCT02851797) trial evaluated givinostat in 179 ambulant boys ≥ 6 years of age with DMD who were on stable corticosteroid therapy for ≥ 6 months. The mean age was 9.8 years. Patients were randomized 2:1 to oral givinostat or placebo for 18 months. The primary endpoint was change from baseline to 18 months in time required to climb 4 standard stairs in the target population (n=120) which included boys with baseline vastus lateralis muscle fat fraction (VL MFF) between >5% and ≤ 30% based on magnetic resonance spectroscopy (MRS) assessment. The study demonstrated a slower decline to climb 4 stairs with givinostat compared to placebo (difference versus placebo, 1.78 seconds; p=0.0345). Significant improvements in the secondary endpoints of North Star Ambulatory Assessment (NSAA) (p=0.02) and the time to rise (TTR) test were also reported with givinostat compared to placebo. In addition, data demonstrated that givinostat led to a significant delay in fat infiltration by approximately 30% (difference versus placebo, -2.9%; nominal p=0.035). The most common adverse events reported with givinostat were GI disturbances, thrombocytopenia, pyrexia and hypertriglyceridemia. Givinostat oral suspension was administered as a weight-based dose twice daily.

PLACE IN THERAPY

DMD is a rare, X-linked neuromuscular disorder characterized by progressive muscle degeneration and weakness. An estimated 400 to 600 boys are born with DMD each year in the U.S. In DMD, gene mutations lead to a lack of functional dystrophin protein involved in maintaining muscle fiber integrity. Onset of signs and symptoms of DMD occurs between 3 to 5 years of age. Most boys affected lose the ability to walk by age 12. Moreover, death due to respiratory or cardiac failure typically occurs by the early 30s. Select corticosteroids (prednisone) have been used historically to treat DMD, and deflazacort (Emflaza®) is the only steroid FDA-approved for DMD. Corticosteroids may be used in combination with other agents for DMD, including casimersen (Amondys 45), eteplirsen (Exondys 51), golodirsen (Vyondys 53) and viltolarsen (Viltepso®). While corticosteroids have been a SOC in DMD to delay progression of muscle weakness and improve respiratory function, their use is associated with side effects such as weight gain, slowed growth trajectories, bone fractures and cataracts. Recently, Sarepta’s delandistrogene moxeparvovec-rokl (Elevydis) became the first gene therapy approved, via Accelerated Approval, to treat DMD. In addition, Santhera’s oral steroid vamorolone was submitted to the FDA for DMD, with an anticipated FDA decision by October 26, 2023. HDAC enzymes alter the 3-dimensional folding of DNA and thereby prevent gene translation. In DMD, higher than normal HDAC activity may prevent muscle regeneration and elicit inflammation. In clinical trials, HDAC inhibition by givinostat slowed disease progression, significantly increased muscle mass, and significantly reduced fibrotic tissue, muscle tissue necrosis and fatty replacement. If approved, givinostat will be an additional option in the growing armamentarium for DMD.

FDA APPROVAL TIMELINE December 21, 2023  Fast Track

 Orphan Drug

 Priority Review

 RPD

FINANCIAL FORECAST (reported in millions) Year

2023

2024

2025

2026

2027

Projected Total U.S. Sales

$237

$267

$383

$541

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METABOLIC

resmetirom oral Madrigal PROPOSED INDICATIONS

Non-alcoholic steatohepatitis (NASH) with liver fibrosis

CLINICAL OVERVIEW

Resmetirom is a thyroid hormone receptor (THR)-β selective agonist. It works by treating the underlying disease in patients with NASH by decreasing liver fat, thereby reducing lipotoxicity to induce NASH resolution. The double-blind, phase 3 MAESTRO-NASH trial (NCT03900429) evaluated resmetirom in adults with biopsyconfirmed NASH with fibrosis. Patients were randomized 1:1:1 to receive resmetirom 80 mg, resmetirom 100 mg or placebo. After 52 weeks, significantly more patients treated with resmetirom experienced improvement in the co-primary endpoints compared to placebo: Primary Endpoint

resmetirom 80 mg

resmetirom 100 mg

placebo

NASH resolution (ballooning 0, inflammation 0,1) with ≥2-point reduction in NAS and no worsening of fibrosis

26% (p<0.0001)

30% (p<0.0001)

10%

≥1-stage improvement in fibrosis with no worsening of NAS

24% (p=0.0002)

26% (p<0.0001)

14%

Improvements in fibrosis and NASH were seen regardless of gender, age, T2DM status, baseline fibrosis stage or NAS (< 6, ≥ 6). Atherogenic lipids and lipoproteins (e.g., LDL-C and triglycerides) also decreased with resmetirom treatment. Resmetirom was generally well tolerated. The most common TEAEs were mild, transient diarrhea and nausea reported at therapy initiation. No cases of drug-induced liver injury were reported. The MAESTRO-NASH-OUTCOMES study is underway to evaluate resmetirom 80 mg on liver-related outcomes in adults with well-compensated (Child-Pugh A) NASH cirrhosis plus all-cause mortality and may serve as the confirmatory data for potential full approval. Study completion is expected in 2025. Resmetirom was administered orally once daily.

PLACE IN THERAPY

NASH is an advanced form of NAFLD. According to the NIH, an estimated 24% of adults in the U.S. have NAFLD, and approximately 1.5% to 6.5% have NASH. NASH is characterized by accumulation of fat in the liver (steatosis), liver inflammation, hepatocyte injury (ballooning), with or without fibrosis, and ultimately cirrhosis. NASH is a leading cause of liver cancer and the second most common indication for liver transplantation. The condition is closely associated with metabolic disorders, such as obesity, metabolic syndrome and diabetes. CVD is also associated with NASH and is a leading cause of death among patients with NASH, particularly in those with fibrosis stage ≥ 2. NASH can occur at any age, but is typically diagnosed between the ages of 40 and 60 years, when irreversible liver damage becomes evident. Moreover, incidence of NASH is rising in pediatrics, due in part to an increase in childhood obesity. There are no FDA-approved drugs to treat NASH. There have been setbacks in the development of medications to treat NASH, including the failure of Intercept’s obeticholic acid (Ocaliva®) to receive FDA approval for the condition, and the sponsor’s subsequent suspension of NASH activity. Current treatment consists of lifestyle management (weight loss, exercise, alcohol avoidance) as well as management of diabetes, hyperlipidemia and hypertension. If approved, resmetirom will be the first medication available in the U.S. to treat NASH. In the phase 3 trial, its use led to resolution of NASH and reduction of liver fibrosis, both surrogate endpoints that the FDA proposed as being reasonably likely to predict clinical benefit and which would support Accelerated Approval. Resmetirom is also in phase 3 trials for NAFLD.

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resmetirom cont. FDA APPROVAL TIMELINE

March 14, 2024 (No FDA advisory committee review of resmetirom is currently planned.)  seeking Accelerated Approval

 Breakthrough Therapy

 Fast Track

 Priority Review

FINANCIAL FORECAST (reported in millions) Year

2023

2024

2025

2026

2027

Projected Total U.S. Sales

$172

$498

$927

$1,356

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HEMATOLOGY

TAK-755 IV Takeda PROPOSED INDICATIONS

Congenital thrombotic thrombocytopenic purpura (cTTP)

CLINICAL OVERVIEW

TAK-755 is a recombinant disintegrin and metalloproteinase with a thrombospondin type 1 motif, member 13 (ADAMTS13) protein. An open-label, phase 3 trial (NCT03393975) evaluated TAK-755 in 38 patients 0 to 70 years of age with cTTP. Patients were randomized 1:1 to TAK-755 or SOC (e.g., plasma-based therapies) during months 1 through 6 (period 1), after which both groups were switched to the alternate treatment during months 7 through 12 (period 2). Following that, all patients received TAK-755 during months 13 through 18 (period 3). An interim analysis included data from 38 patients who were 12 to 58 years of age and had a mean TAK-755 exposure of 13.2 months. Data revealed that zero acute thrombotic thrombocytopenic purpura (TTP) episodes occurred during TAK-755 treatment and 1 event occurred during SOC treatment. TEAEs were reported in 10.3% of patients during TAK-755 treatment and 50% during SOC treatment. No drug neutralizing antibodies toward TAK-755 were detected. Pharmacokinetic characteristics were also assessed after a single infusion of TAK-755 in 36 patients ≥ 12 years of age and revealed an ADAMTS13 activity level 5 times higher in patients treated with TAK-755 compared to those given plasma-based therapy (maximum serum concentration, 100% versus 19%, respectively). Comparable results were reported in an open-label, phase 3b continuation study (NCT04683003). In the phase 3 trials, TAK-755 was administered as 40 IU/kg IV every week or every other week, based on the patient’s regimen at enrollment.

PLACE IN THERAPY

cTTP is an ultra-rare inherited condition affecting approximately 1 in 1,000,000 individuals. It is characterized by chronic microvascular thrombosis. cTTP has been associated with several ADAMTS13 gene mutations that lead to a deficiency of the ADAMTS13 enzyme, a von Willebrand factor (VWF)-cleaving protein. Signs and symptoms of cTTP typically present during childhood but can start at any age, most notably during pregnancy. Disease complications include ischemic injury of the brain, heart and kidneys, with a mortality rate of > 90% if left untreated. Treatment for cTTP focuses on replacement of the ADAMTS13 enzyme, usually by way of IV infusion of fresh-frozen plasma (FFP). Prophylactic plasma transfusion is recommended during pregnancy; however, a watch-and-wait approach may be taken outside of pregnancy. If approved, TAK-755 will be the first and only pharmacological treatment that replenishes ADAMTS13, thereby addressing the underlying cause of cTTP. In clinical trials, this enzyme replacement therapy demonstrated a tolerable safety profile and efficacy in preventing acute TTP events. TAK-755 is also being evaluated for immune-mediated TTP (phase 2b), acquired TTP (phase 2), and SCD (phase 2.

FDA APPROVAL TIMELINE November 16, 2023  Fast Track

 Orphan Drug

 Priority Review

 RPD

FINANCIAL FORECAST (reported in millions) Year

2023

2024

2025

2026

2027

Projected Total U.S. Sales

$32

$76

$148

$213

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ONCOLOGY

zolbetuximab IV Astellas PROPOSED INDICATIONS

Gastric or gastroesophageal junction (G/GEJ) adenocarcinoma that is locally advanced unresectable or metastatic, HER2-negative, and is CLDN18.2-positive as 1st-line treatment

CLINICAL OVERVIEW

Zolbetuximab is a chimeric IgG1 monoclonal antibody. It binds to the transmembrane protein Claudin-18 isoform 2 (CLDN18.2) on the tumor surface and activates antibody- and complement-dependent cytotoxicity. Zolbetuximab has been evaluated in 2 double-blind, phase 3, clinical trials, SPOTLIGHT (NCT03504397) and GLOW (NCT03653507), in adults with CLDN18.2-positive, HER2-negative, untreated, locally advanced unresectable or metastatic G/GEJ adenocarcinoma. In SPOTLIGHT, 565 patients were randomized 1:1 to zolbetuximab or placebo; each was added to mFOLFOX6 (folinic acid + 5-FU + oxaliplatin) chemotherapy. At a median follow-up of approximately 12 months, the median PFS (primary endpoint) was 10.61 months with zolbetuximab and 8.67 months with placebo (HR, 0.751; p=0.0066). The OS was 18.23 months with zolbetuximab and 15.54 months with placebo (HR, 0.75; p=0.0053), and ORR was 48% in each group. In GLOW, 507 patients were randomized to zolbetuximab or placebo; each was added to CAPOX (oral capecitabine + oxaliplatin) chemotherapy. The study demonstrated a significantly longer median PFS (primary endpoint) with zolbetuximab compared to placebo (8.21 versus 6.8 months, respectively; HR, 0.687; p=0.0007). OS was also significantly longer with zolbetuximab (14.39 versus 12.16 months, respectively; HR, 0.771; p=0.0118). Further, among patients with measurable disease, the ORR was 53.8% and 48.8% with zolbetuximab and placebo, respectively. In both trials, the most common TEAEs were nausea, vomiting and decreased appetite. Grade ≥ 3 TEAEs were reported with zolbetuximab and placebo (SPOTLIGHT, 87% versus 78%, respectively; GLOW, 72.8% versus 69.9%, respectively) and included nausea, vomiting and decreased appetite. Treatment-related death occurred in 2% and 1% of patients in the SPOTLIGHT zolbetuximab and placebo groups, respectively, and in 2.4% and 2.8% of the GLOW zolbetuximab and placebo groups, respectively. Zolbetuximab was infused IV as an 800 mg/m2 loading dose, followed by 600 mg/m2 every 3 weeks.

PLACE IN THERAPY

Gastric cancer (GC) risks include Helicobacter pylori infection, tobacco smoking, high salt intake, and high alcohol consumption. In the U.S., the incidence of GC is declining, due in part to a decrease in H. pylori infection and improved food preservation; however, data suggest that the incidence of early-onset GC is rising. It is estimated that 26,500 new cases of GC will be diagnosed, and 11,130 deaths will occur due to the condition in the U.S. in 2023. Advanced GC has a high frequency of recurrence and metastasis and a poor prognosis. The preferred 1st-line chemotherapy for unresectable locally advanced or metastatic GC is the combination of a fluoropyrimidine (5-FU or capecitabine) and oxaliplatin. Depending on tumor characteristics, targeted agents such as trastuzumab (HER2-positive) and checkpoint inhibitors (PD-L1 combined positive score [CPS] ≥ 5; MSI-H/dMMR) may be added. However, an unmet need still remains in the GC space. CLDN18.2 is a tight junction protein expressed exclusively in healthy gastric mucosa cells and is retained in gastric tumor cells making it a potential target for GC treatment. Zolbetuximab is a first-in-class CLDN18.2directed antibody. In clinical trials, when added to SOC chemotherapy regimens, it significantly prolonged PFS and OS compared to chemotherapy alone. If approved, zolbetuximab may help fulfill this unmet need in 1stline GC treatment. The agent is also being evaluated for pancreatic cancer as a CLDN18.2-targeting therapy.

FDA APPROVAL TIMELINE January 12, 2024  Orphan Drug

 Priority Review

 RTOR

FINANCIAL FORECAST (reported in millions) Year

2023

2024

2025

2026

2027

Projected Total U.S. Sales

$37

$68

$141

$165

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Biosimilars CLINICAL OVERVIEW

Biosimilars are very different from generic drugs in that they are not exact duplicates of their reference biologic product. The FDA approval process for biosimilars is designed to ensure that the biosimilar product is highly similar to the reference product without having any meaningful clinical differences. Moreover, an interchangeable biological product is a biosimilar that is expected to produce the same clinical result as the reference product in any given patient. Switching or alternating between the reference and interchangeable products should have been evaluated by the sponsor and should not negatively impact the safety and efficacy of therapy. Many controversies have surrounded biosimilars, and regulatory and litigation hurdles remain. The FDA has issued final and draft guidances. Select FDA biosimilar guidances are noted here. In January 2017, the agency issued final guidance on the nonproprietary naming of biologic products, which also applies to biosimilars. The biologic products must bear a core name followed by a distinguishing 4-letter, lowercase, hyphenated suffix that is devoid of meaning. The international nonproprietary name (INN) impacts interchangeability as it affects pharmacists’ ability to substitute an interchangeable biosimilar for the reference product. The FDA withdrew the September 2017 draft industry guidance on determining similarity of a proposed biosimilar product to its reference product to allow for further consideration of the most current and relevant scientific methods in evaluating analytical data. The agency focuses on providing flexibility for the efficient development of biosimilars while maintaining high scientific standards. In July 2018, the FDA finalized its guidance on labeling biosimilars. The guidance pertains to prescribing information (PI) but does not contain specific recommendations on interchangeability in the labeling. The labeling guidance provides recommendations on how to include, identify and differentiate the biosimilar and the reference product in various sections of the PI. The basic premise remains that the originator product’s safety and effectiveness can be relied upon for HCPs to make prescribing decisions; therefore, a biosimilar should include relevant data from the originator in its PI. In May 2019, the agency released its final guidance on interchangeability. Most states have enacted biosimilar substitution laws. An interchangeable product may be substituted for the originator at the pharmacy without the involvement of the prescriber. In December 2022, the FDA announced a pilot regulatory science program that focuses on advancing the development of interchangeable products and improving the efficiency of biosimilar product development. The Purple Book is an FDA database of licensed biological products that lists biosimilar and interchangeable products. The FDA has approved 6 biosimilars for interchangeability to their reference product: adalimumab-adbm (Cyltezo®), adalimumab-afzb (Abrilada™), insulin glargine-yfgn (Semglee®), insulin glargineaglr (Rezvoglar™), ranibizumab-eqrn (Cimerli™) and ranibizumab-nuna (Byooviz™). Biosimilars can receive extrapolation to gain an indication without direct trials of the biosimilar for the eligible indication(s) of the reference products without requiring additional trials. Nevertheless, as each biosimilar comes to market, it will need to be considered individually. Historically, the FDA regulated insulins as small molecules. However, effective March 23, 2020, drugs such as insulin and growth hormone were deemed biologics and transitioned from the drug pathway to the biologic pathway. Their licensure as biologics allows these agents to be considered in the biosimilar space and promotes competition and access.

PLACE IN THERAPY

The patents of several biologic drugs are set to expire in the next few years, opening the U.S. market for biosimilar entry; however, patent litigation has resulted in significant launch delays of FDA-approved biosimilars. In June 2017, the U.S. Supreme Court issued 2 landmark rulings: (1) allowing a biosimilar manufacturer to provide launch notice of commercial marketing to the originator manufacturer before or after FDA approval of the biosimilar product; and (2) eliminating any federal requirement for disclosure, also known as the “patent dance.” Some states, however, mandate disclosure. These decisions may bring biosimilars to the market sooner and potentially create price competition in the marketplace. In July 2018, the FDA unveiled its Biosimilar Action Plan (BAP), a series of 11 steps to encourage biosimilar market competition, some of which were previously announced or underway. The BAP contains 4 key strategies: (1) improve the biosimilar development and approval process; (2) maximize scientific and regulatory clarity for sponsors; (3) provide effective communications for patients, clinicians and payers; and (4) reduce unfair tactics that may delay market approval and entry. The BAP strives to promote access to biosimilar products and reduce health care costs.

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BIOSIMILARS continued To date, a total of 43 biosimilars have received FDA approval. Of these, 37 have entered the market. APPROVED BIOSIMILARS Brand Name (Nonproprietary name)

Manufacturer

Approval Date

Zaxio® (filgrastim-sndz)

Sandoz

March 2015

Inflectra® (infliximab-dyyb)

Pfizer

April 2016

Erelzi® (etanercept-szzs)

Sandoz

August 2016

Amjevita™* (adalimumab-atto)

Amgen

September 2016

Renflexis® (infliximab-abda)

Merck/Organon

May 2017

Cyltezo* (adalimumab-adbm)

Boehringer Ingelheim

August 2017

Mvasi® (bevacizumab-awwb)

Amgen

September 2017

Ixifi™ † (infliximab-qbtx)

Pfizer

December 2017

Ogivri® (trastuzumab-dkst)

Mylan/Biocon

December 2017

Retacrit® (epoetin alfa-epbx)

Pfizer/Vifor/ Hospira

May 2018

Fulphila® (pegfilgrastim-jmdb)

Mylan/Biocon

June 2018

Nivestym® (filgrastim-aafi)

Pfizer

July 2018

Hyrimoz®* (adalimumab-adaz)

Sandoz

October 2018

Udenyca (pegfilgrastim-cbqv)

Coherus

November 2018

Truxima® (rituximab-abbs)

Cephalon/Teva

November 2018

Herzuma® (trastuzumab-pkrb)

Teva

December 2018

Ontruzant® (trastuzumab-dttb)

Merck

January 2019

Trazimera® (trastuzumab-qyyp)

Pfizer

March 2019

Eticovo™ (etanercept-ykro)

Samsung Bioepis

April 2019

Kanjinti® (trastuzumab-anns)

Amgen

June 2019

Zirabev® (bevacizumab-bvzr)

Pfizer

June 2019

Hadlima™* (adalimumab-bwwd)

Organon

July 2019

Ruxience® (rituximab-pvvr)

Pfizer

July 2019

Abrilada* (adalimumab-afzb)

Pfizer

November 2019

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Interchangeable -

 -



Commercially Available

  -

    -

Originator (Manufacturer) Neupogen® (Amgen) Remicade® (Janssen) Enbrel® (Amgen) Humira® (Abbvie) Remicade (Janssen) Humira (Abbvie) Avastin® (Genentech) Remicade (Janssen)

    

Herceptin® (Genentech)

    

Neulasta (Amgen)

(only HCF)

    -

Epogen® (Amgen) Procrit® (Janssen) Neulasta® (Amgen) Neupogen (Amgen) Humira (Abbvie)

Rituxan® (Genentech) Herceptin (Genentech) Herceptin (Genentech) Herceptin (Genentech) Enbrel (Amgen) Herceptin (Genentech) Avastin (Genentech) Humira (Abbvie) Rituxan (Genentech) Humira (Abbvie)

BIOSIMILARS continued APPROVED BIOSIMILARS continued APPROVED BIOSIMILARS Brand Name (Nonproprietary name)

Manufacturer

Approval Date

Ziextenzo® (pegfilgrastim-bmez)

Sandoz

November 2019

Avsola® (infliximab-axxq)

Amgen

December 2019

Nyvepria™ (pegfiltrastim-apgf)

Pfizer

June 2020

Semglee (insulin glargine-yfgn)

Mylan/Biocon

June 2020

Hulio®* (adalimumab-fkjp)

Mylan/Biocon

July 2020

Riabni™ (rituximab-arrx)

Amgen

December 2020

Byooviz (ranibizumab-nuna)

Biogen

September 2021

Rezvoglar (insulin glargine-aglr)

Eli Lilly

December 2021

Yusimry™* (adalimumab-aqvh)

Coherus

December 2021

Releuko® (filgrastim-ayow)

Amneal

March 2022

Alymsys® (bevacizumab-maly)

Amneal

April 2022

Fylnetra® (pegfilgrastim-pbbk)

Amneal

May 2022

Cimerli (ranibizumab-eqrn)

Coherus

August 2022

Stimufend® (pegfilgrastim-fpgk)

Fresenius Kabi

September 2022

Vegzelma® (bevacizumab-adcd)

Celltrion

September 2022

Idacio® (adalimumab-aacf)

Fresenius Kabi

December 2022

Yuflyma®* (adalimumab-aaty)

Celltrion

May 2023

Tyruko-sztn® (natalizumab-sztn)

Sandoz

August 2023

Tofidence™ (tocilizumab-bavi)

Biogen/Bio-Thera Solutions

September 2023

Interchangeable -

 -

  -

 -

Commercially Available

                

Originator (Manufacturer) Neulasta (Amgen) Remicade (Janssen) Neulasta (Amgen) Lantus® (Sanofi-Aventis) Humira (Abbvie) Rituxan (Genentech) Lucentis® (Genentech) Lantus (Sanofi) Humira (Abbvie) Neupogen (Amgen) Avastin (Genentech) Neulasta (Amgen) Lucentis (Genentech) Neulasta (Amgen) Avastin (Genentech) Humira (Abbvie) Humira (Abbvie)

Tysabri® (Biogen)

Actemra® (Genentech)

* Abbvie’s adalimumab (Humira), adalimumab-adaz (Hyrimoz), and adalimumab-bwwd (Hadlima) are approved in 50 mg/mL (with citric acid/ citrate) and 100 mg/mL (citrate-free) concentrations. Adalimumab-aaty (Yuflyma) is only approved as a 100 mg/mL high concentration citrate-free formulation. All other biosimilars for Humira are approved as 50 mg/mL concentrations only. † Pfizer’s Inflectra is marketed in the U.S.; Pfizer has not announced plans to launch Ixifi.

Also available are Eli Lilly’s Basaglar® insulin glargine, a follow-on to Sanofi’s Lantus, and Sanofi’s Admelog® insulin lispro approved as a follow-on to Eli Lilly’s Humalog®. Specialty medications, which include biologics, continue to grow and constitute a large part of drug spend. In the U.S., it is estimated that biosimilars will cost approximately 15% to 35% less than the originator product, although price dynamics vary. Further, the potential cost savings can vary based on the market segment where brand contracts can play a role. A host of factors will contribute to market acceptability and the potential success of biosimilars. Payers, pharmacies, prescribers and patients each play an important role in market adoption of biosimilars.

15 | MAGELLANRX.COM

BIOSIMILARS continued The first biosimilar version of Abbvie’s adalimumab (Humira), adalimumab-atto (Amjevita) became available in the U.S. in January 2023. Several Humira biosimilars, including citrate-free and high-concentration formulations as well as an interchangeable product, launched in July 2023.

IMMUNOLOGY

adalimumab SC Alvotech is seeking approval of their investigational biosimilar to Abbvie’s citrate-free, high-concentration (100 mg/ mL) Humira. Celltrion is seeking interchangeability for their FDA-approved adalimumab-aaty (Yuflyma) 100 mg/mL, a biosimilar to citrate-free, high-concentration (100 mg/mL) Humira. Abbvie’s Humira is a tumor necrosis factor alpha (TNF-α) blocker indicated for the treatment of autoimmune disorders, including rheumatoid arthritis (RA), juvenile idiopathic arthritis (JIA), ankylosing spondylitis (AS), plaque psoriasis (PSO), psoriatic arthritis (PsA), Crohn’s disease (CD) in adults and children, ulcerative colitis (UC), hidradenitis suppurativa (HS), and non-infectious uveitis.

FDA APPROVAL TIMELINE

• Alvotech (AVT-02) – February 24, 2024 • Celltrion (Yuflyma) – October to December 2024 for interchangeability

FINANCIAL FORECAST (reported in millions) Year

2023

2024

2025

2026

2027

Projected Total U.S. Sales

$12,164

$7,409

$5,567

$4,655

$4,038

The forecast is a projection of total U.S. sales per year for the branded originator product.

OPHTHALMOLOGY

aflibercept intravitreal Biocon/Janssen, Celltrion and Coherus are seeking approval of their investigational biosimilars to Regeneron’s Eylea®, a vascular endothelial growth factor (VEGF) inhibitor indicated for the treatment of neovascular (wet) age-related macular degeneration (AMD), macular edema following retinal vein occlusion (RVO), diabetic macular edema (DME), and diabetic retinopathy (DR).

FDA APPROVAL TIMELINE

• Biocon/Janssen (MYL-1701) – Pending • Celltrion (CT-P42) – June 28, 2024 • Coherus (FYB-203) – June 28, 2024

FINANCIAL FORECAST (reported in millions) Year

2023

2024

2025

2026

2027

Projected Total U.S. Sales

$6,138

$5,469

$4,388

$2,896

$2,037

The forecast is a projection of total U.S. sales per year for the branded originator product.

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BIOSIMILARS continued

ONCOLOGY

bevacizumab IV Bio-Thera Solutions/Sandoz and Centus are seeking approval for their investigational biosimilars to Genentech’s Avastin, a vascular endothelial growth factor (VEGF)-specific angiogenesis inhibitor indicated for the treatment of metastatic colorectal cancer, nonsquamous non-small cell lung cancer, glioblastoma, metastatic renal cell carcinoma (RCC), and recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer.

FDA APPROVAL TIMELINE

• Bio-Thera Solutions/Sandoz (BAT1706) – Pending • Centus (FKB238) – Pending

FINANCIAL FORECAST (reported in millions) Year

2023

2024

2025

2026

2027

Projected Total U.S. Sales

$507

$432

$387

$348

$315

The forecast is a projection of total U.S. sales per year for the branded originator product.

ENDOCRINE

denosumab SC Sandoz Sandoz is seeking approval for their investigational biosimilar (GP2411) to Amgen’s receptor activator of nuclear factorkappa-B ligand (RANKL) inhibitor denosumab (Prolia®, Xgeva®). Prolia is indicated for the treatment of osteoporosis in men and postmenopausal women, treatment of glucocorticoid-induced osteoporosis in men and women, and to increase bone mass in women receiving adjuvant aromatase inhibitor therapy or men receiving androgen deprivation therapy; all indicated populations are high risk for fracture. Xgeva is indicated for the prevention of skeletal-related events in patients with multiple myeloma and in patients with bone metastases from solid tumors, treatment of select patients with giant cell tumor of bone, and treatment of hypercalcemia of malignancy refractory to bisphosphonate therapy.

FDA APPROVAL TIMELINE December 6, 2023

FINANCIAL FORECAST (reported in millions) Year

2023

2024

2025

2026

2027

Projected Total U.S. Sales

$4,245

$4,441

$4,551

$3,895

$3,116

The forecast is a projection of total U.S. sales per year for the branded originator product.

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BIOSIMILARS continued

IMMUNOLOGY

eculizumab IV Amgen Amgen is seeking approval for their investigational biosimilar (Bekemv) to Alexion’s complement inhibitor eculizumab (Soliris®) that is indicated for the treatment of paroxysmal nocturnal hemoglobinuria (PNH) and atypical hemolytic uremic syndrome (aHUS).

FDA APPROVAL TIMELINE February 2024

FINANCIAL FORECAST (reported in millions) Year

2023

2024

2025

2026

2027

Projected Total U.S. Sales

$1,708

$1,284

$968

$654

$483

The forecast is a projection of total U.S. sales per year for the branded originator product.

BLOOD MODIFIER

filgrastim IV, SC Apotex Apotex is seeking approval of their investigational biosimilar (Grastofil) to Amgen’s Neupogen, a leukocyte growth factor indicated for use in patients with nonmyeloid malignancies who are receiving myelosuppressive anti-cancer drugs; following induction or consolidation chemotherapy for acute myeloid leukemia (AML); with nonmyeloid malignancies in patients who are undergoing myeloablative chemotherapy followed by bone marrow transplantation; to mobilize autologous hematopoietic progenitor cells for collection by leukapheresis; with symptomatic congenital neutropenia‚ cyclic neutropenia‚ or idiopathic neutropenia; and who are acutely exposed to myelosuppressive doses of radiation (hematopoietic syndrome of acute radiation syndrome [HSARS]).

FDA APPROVAL TIMELINE Pending

FINANCIAL FORECAST (reported in millions) Year

2023

2024

2025

2026

2027

Projected Total U.S. Sales

$45

$32

$25

$19

$15

The forecast is a projection of total U.S. sales per year for the branded originator product.

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BIOSIMILARS continued

ENDOCRINOLOGY

insulin aspart SC Gan & Lee/Sandoz Gan & Lee/Sandoz are seeking approval for their investigational biosimilar (GL-ASP) to Novo Nordisk’s rapid-acting human insulin analog insulin aspart (Novolog®) that is indicated to improve glycemic control in patients with diabetes mellitus.

FDA APPROVAL TIMELINE April 14, 2023

FINANCIAL FORECAST (reported in millions) Year

2023

2024

2025

2026

2027

Projected Total U.S. Sales

$716

$665

$630

$605

$579

The forecast is a projection of total U.S. sales per year for the branded originator product.

ENDOCRINOLOGY

insulin glargine SC Gan & Lee/Sandoz Gan & Lee/Sandoz are seeking approval for their investigational biosimilar (Basalin) to Sanofi-Aventis’ long-acting human insulin analog insulin glargine (Lantus) that is indicated to improve glycemic control in patients with diabetes mellitus.

FDA APPROVAL TIMELINE December 23, 2023

FINANCIAL FORECAST (reported in millions) Year

2023

2024

2025

2026

2027

Projected Total U.S. Sales

$450

$384

$337

$297

$263

The forecast is a projection of total U.S. sales per year for the branded originator product.

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BIOSIMILARS continued

ENDOCRINOLOGY

insulin lispro SC Gan & Lee/Sandoz Gan & Lee/Sandoz are seeking approval for their investigational biosimilar (Prandilin) to Eli Lilly’s rapid-acting human insulin analog insulin lispro (Humalog) that is indicated to improve glycemic control in patients with diabetes mellitus.

FDA APPROVAL TIMELINE April 1, 2024

FINANCIAL FORECAST (reported in millions) Year

2023

2024

2025

2026

2027

Projected Total U.S. Sales

$1,032

$850

$781

$723

$672

The forecast is a projection of total U.S. sales per year for the branded originator product.

BLOOD MODIFIER

pegfilgrastim SC Apotex and Lupin are seeking approval for their investigational biosimilars to Amgen’s Neulasta, and Coherus is seeking approval for their investigational biosimilar to Amgen’s Neulasta Onpro®. Neulasta and Neulasta Onpro contain pegfilgrastim, a leukocyte growth factor indicated for use in patients with nonmyeloid malignancies who are receiving myelosuppressive anti-cancer drugs and in patients acutely exposed to myelosuppressive doses of radiation (HSARS).

FDA APPROVAL TIMELINE

• Apotex (Lapelga) – Pending • Coherus (Udenyca OBI®) – October to December 2023 • Lupin (Lupifil-P) – Pending

FINANCIAL FORECAST (reported in millions) Year

2023

2024

2025

2026

2027

Projected Total U.S. Sales Neulasta

$622

$420

$347

$283

$234

Projected Total U.S. Sales Neulasta Onpro

$2,972

$2,576

$2,390

$2,084

$1,833

The forecast is a projection of total U.S. sales per year for the branded originator product (Neulasta and Neulasta Onpro).

20 | MAGELLANRX.COM

BIOSIMILARS continued

OPHTHALMOLOGY

ranibizumab intravitreal Stada Arzneimittel/Xbrane Stada Arzneimittel/Xbrane are seeking approval for their investigational biosimilar (Ximluci) to Genentech’s Lucentis, a vascular endothelial growth factor (VEGF) inhibitor indicated to treat wet age-related macular degeneration (AMD), macular edema following retinal vein occlusion (RVO), diabetic macular edema (DME), diabetic retinopathy, and myopic choroidal neovascularization (mCNV).

FDA APPROVAL TIMELINE April 21, 2024

FINANCIAL FORECAST (reported in millions) Year

2023

2024

2025

2026

2027

Projected Total U.S. Sales

$665

$514

$408

$346

$321

The forecast is a projection of total U.S. sales per year for the branded originator product.

IMMUNOLOGY/ONCOLOGY

rituximab IV Dr. Reddy’s

Dr. Reddy’s is seeking approval for their investigational biosimilar to Genentech’s Rituxan, a CD20-directed cytolytic antibody indicated for the treatment of select patients with non-Hodgkin’s lymphoma (NHL), mature B-cell NHL/mature B-cell acute leukemia, chronic lymphocytic leukemia (CLL), rheumatoid arthritis (RA), granulomatosis with polyangiitis (GPA)/microscopic polyangiitis (MPA), and pemphigus vulgaris.

FDA APPROVAL TIMELINE May 10, 2024

FINANCIAL FORECAST (reported in millions) Year

2023

2024

2025

2026

2027

Projected Total U.S. Sales

$1,122

$914

$761

$679

$606

The forecast is a projection of total U.S. sales per year for the branded originator product.

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BIOSIMILARS continued

IMMUNOLOGY

tocilizumab IV, SC Fresenius Kabi Fresenius Kabi is seeking approval for their investigational biosimilars to Genentech’s Actemra, an interleukin-6 (IL-6) receptor antagonist indicated for the treatment of rheumatoid arthritis (RA), giant cell arteritis, systemic sclerosisassociated interstitial lung disease, polyarticular and systemic juvenile idiopathic arthritis (JIA), and cytokine release syndrome.

FDA APPROVAL TIMELINE Pending

FINANCIAL FORECAST (reported in millions) Year

2023

2024

2025

2026

2027

Projected Total U.S. Sales

$1,141

$895

$719

$604

$528

The forecast is a projection of total U.S. sales per year for the branded originator product.

ONCOLOGY

trastuzumab IV Henlius/Accord Henlius/Accord are seeking approval of their investigational biosimilar (HLX02) to Genentech’s Herceptin, a HER2/ neu receptor antagonist indicated for the treatment of HER2-overexpressing breast cancer and HER2-overexpressing metastatic gastric or gastroesophageal junction adenocarcinoma.

FDA APPROVAL TIMELINE December 15, 2023

FINANCIAL FORECAST (reported in millions) Year

2023

2024

2025

2026

2027

Projected Total U.S. Sales

$360

$299

$261

$229

$197

The forecast is a projection of total U.S. sales per year for the branded originator product.

22 | MAGELLANRX.COM

Keep on Your RADAR Notable agents that are further from approval have been identified in this unique watch list. These are products with the potential for significant clinical and financial impact. Their development status is being tracked on the MRx Pipeline radar. These pipeline products, their respective class or proposed indication, as well as an estimated financial forecast for the year 2027, are displayed. The financials are projected total annual US sales, reported in millions. xanomeline-trospium

aficamten

Behavioral health

Cardiovascular

$1,810

$872

tovorafenib

atidarsagene autotemcel

$374

$89

Metabolic

Oncology

tirzepatide

blarcamesine

$4,969

$1,049

Neurology

Weight management

datopotamab deruxtecan

tabelecleucel Oncology

Oncology

$401

$891

sotatercept

donanemab

Cardiology

Neurology

$1,453

$1,261 fidanacogene elaparvovec

reproxalap

Ophthalmology

$285

Hematology/Gene therapy

$193

prademagene zamikeracel (EB-101)

giroctocogene fitelparvovec

Dermatology/Gene therapy

$129

Hematology/Gene therapy

insulin icodec Endocrine

$318

influenza vaccine (FluMist® Quadrivalent)

$106

(self-/caregiver-administered) Infectious disease

$31 pecialty drug names appear in  S magenta throughout the publication.

Pipeline DRUG LIST The pipeline drug list is an aerial outline of drugs with anticipated FDA approval through 2024. It is not intended to be a comprehensive inventory of all drugs in the pipeline; emphasis is placed on drugs in high-impact categories. Investigational drugs with a Complete Response Letter (CRL).

APPLICATION APPLICATION SUBMITTED SUBMITTED TO THE FDA

IN PHASE PHASE33 TRIALS TRIALS

69%

62%

31%

38%

34%

18%

Specialty

22%

12%

16%

Traditional

Orphan Drug

Priority Review

Breakthrough Therapy

Biosimilar

pecialty drug names appear in  S magenta throughout the publication.

PIPELINE DRUG LIST  Specialty drug names appear in magenta throughout the publication. NAME

MANUFACTURER

DOSAGE FORM

CLINICAL USE

DEVELOPMENT STATUS

FDA DECISION

Submitted (New Drugs) clobetasol propionate

Salvat

Postsurgical ocular pain and inflammation

capivasertib

AstraZeneca

donanemab

505(b)(2) NDA

October 2023

Breast cancer (R/R, Oral HR+/HER2-, locally advanced or metastatic, in combination with fulvestrant, prior endocrine-based therapy)

NDA; Fast Track; Priority Review

Oct-Dec 2023

Eli Lilly

Alzheimer’s disease (early)

IV, SC

BLA; Breakthrough Therapy

Oct-Dec 2023

tirzepatide

Eli Lilly

Obesity/overweight (plus weight-related comorbidities)

NDA; Fast Track

Oct-Dec 2023

tislelizumab

Beigene/Novartis

Esophageal squamous cell carcinoma (unresectable or metastatic, 2nd-line)

BLA; Orphan Drug

Oct-Dec 2023

chikungunya vaccine monovalent, live attenuated

Valneva

Chikungunya infection prevention

BLA; Breakthrough Therapy; Fast Track; Priority Review

November 2023

taurolidine/heparin

Cormedix

Reduction of catheterrelated bloodstream infections (CRBSIs) related to chronic hemodialysis

NDA; Fast Track; QIDP

11/15/2023

TAK-755

Takeda

Thrombotic thrombocytopenic purpura (congenital)

BLA; Fast Track; Orphan Drug; Priority Review; RPD

11/16/2023

vonoprazan

Phathom

Erosive GERD

Oral

NDA

11/17/2023

reproxalap

Aldeyra

DED

Ophthalmic

NDA

11/23/2023

nirogacestat

Springworks/ GlaxoSmithKline

Desmoid tumors

Oral

NDA; Breakthrough Therapy; Fast Track; Orphan Drug; Priority Review; RTOR

11/27/2023

repotrectinib

Bristol-Myers Squibb

NSCLC (ROS1-positive, metastatic, previously treated with one ROS1 tyrosine kinase inhibitor and who have not received prior platinumbased chemotherapy)

Oral

NDA; Breakthrough Therapy; Fast Track; Orphan Drug; Priority Review

11/27/2023

fruquintinib

Takeda

CRC (refractory, metastatic, ≥ 2nd-line)

Oral

NDA; Fast Track; Priority Review

11/30/2023

denosumab (biosimilar to Amgen’s Prolia/Xgeva)

Sandoz

Osteoporosis/osteopenia

BLA

12/06/2023

exagamglogene autotemcel

Vertex/CRISPR

SCD (severe)

BLA; Fast Track; Orphan Drug; Priority Review; RPD; RMAT

12/08/2023

trastuzumab (biosimilar to Genentech’s Herceptin)

Henlius/Accord

Breast cancer; Gastric or gastroesophageal junction adenocarcinoma

BLA

12/15/2023

25 | MAGELLANRX.COM

Ophthalmic

PIPELINE DRUG LIST continued NAME

MANUFACTURER

DOSAGE FORM

CLINICAL USE

DEVELOPMENT STATUS

FDA DECISION

roflumilast foam

Arcutis

Seborrheic dermatitis (ages ≥ 9 years)

Topical

NDA

12/16/2023

aprocitentan

Idorsia

Hypertension (resistant)

Oral

NDA

12/19/2023

lovotibeglogene autotemcel

Bluebird Bio

SCD (severe)

BLA; Fast Track; Orphan Drug; Priority Review; RPD; RMAT

12/20/2023

givinostat

Italfarmaco

DMD

Oral

NDA; Fast Track; Orphan Drug; Priority Review; RPD

12/21/2023

eplontersen

Ionis/AstraZeneca

Transthyretin amyloid polyneuropathy

NDA; Orphan Drug

12/22/2023

travoprost implant

Glaukos

Glaucoma/ocular hypertension

Intraocular

505(b)(2) NDA

12/22/2023

insulin glargine (biosimilar to Sanofi-Aventis' Lantus)

Gan & Lee/Sandoz

T1DM; T2DM

BLA

12/23/2023

gefapixant

Merck

Chronic cough

Oral

NDA

12/27/2023

dihydroergotamine nasal powder

Satsuma

Migraine (acute treatment)

Intranasal

505(b)(2) NDA

January 2024

budesonide viscous oral suspension

Takeda

Eosinophilic esophagitis

Oral

505(b)(2) NDA; Breakthrough Therapy; Orphan Drug

Jan-Feb 2024

insulin icodec

Novo Nordisk

T2DM

BLA

Jan-Jun 2024

cosibelimab

Checkpoint

Cutaneous squamous cell carcinoma (metastatic)

BLA

01/04/2024

berdazimer

Ligand

Molluscum contagiosum

Topical

NDA

01/05/2024

zolbetuximab

Astellas

Gastric cancer (unresectable or metastatic, HER2-, CLDN18.2+, 1st-line)

BLA; Orphan Drug; Priority Review; RTOR

01/12/2024

immunoglobulin (human)

Primary immunodeficiencies

BLA

01/13/2024

scopolamine

Repurposed Therapeutics

Motion sickness

Intranasal

NDA; Priority Review

01/26/2024

atropine 0.01%

Nevakar

Myopia (pediatrics)

Ophthalmic

505(b)(2) NDA

01/31/2024

eculizumab (biosimilar to Alexion’s Soliris)

Amgen

PNH; Hemolytic uremic syndrome (atypical)

BLA

February 2024

mirikizumab

Eli Lilly

IV, SC

BLA

02/08/2024

cefepime/taniborbactam

Venatorx

UTI (complicated)

NDA; Fast Track; Priority Review; QIDP

02/22/2024

adalimumab (biosimilar to Abbvie’s Humira)

Alvotech

RA; AS; PSO; PsA; JIA; CD; UC

BLA

02/24/2024

lifileucel

Iovance

Melanoma (advanced unresectable or metastatic, after antiPD-1/PD-L1 and targeted therapy)

BLA; seeking 02/24/2024 Accelerated Approval; Fast Track; Orphan Drug; Priority Review; RMAT

roluperidone

Minerva

Schizophrenia (negative symptoms)

Oral

NDA

02/26/2024

clobetasol propionate

Formosa

Ocular pain &/or inflammation

Ophthalmic

505(b)(2) NDA

03/04/2024

glatiramer depot

Viatris

505(b)(2) NDA

03/08/2024

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PIPELINE DRUG LIST continued NAME

MANUFACTURER

DOSAGE FORM

CLINICAL USE

DEVELOPMENT STATUS

FDA DECISION

resmetirom

Madrigal

NASH (liver fibrosis)

Oral

NDA; seeking Accelerated Approval; Breakthrough Therapy; Fast Track; Priority Review

03/14/2024

atidarsagene autotemcel

Orchard

Metachromatic leukodystrophy

BLA; Orphan Drug; Priority Review; RPD; RMAT

03/18/2024

vadadustat

Akebia

Anemia due to CKD (dialysis-dependent)

Oral

NDA

03/28/2024

exagamglogene autotemcel

Vertex/CRISPR

Beta-thalassemia (transfusion-dependent)

BLA; Fast Track; Orphan Drug; RPD; RMAT

03/30/2024

marnetegragene autotemcel

Rocket

Leukocyte adhesion deficiency-I

BLA; Fast Track; Orphan Drug; Priority Review; RMAT

03/31/2024

odronextamab

Regeneron

DLBCL (R/R); Follicular lymphoma (R/R)

BLA; Fast Track; Orphan Drug; Priority Review

03/31/2024

RSV pre-fusion F protein vaccine (mRNA-1345)

Moderna

RSV prevention (ages > 60 years)

BLA; Breakthrough Therapy; Fast Track

April 2024

ceftobiprole medocaril

Basilea

ABSSSI; CAP; Staphylococcus aureus bacteremia

NDA; Fast Track; QIDP

Apr-Jun 2024

fidanacogene elaparvovec

Pfizer/Genentech

Hemophilia B (adults)

BLA; Breakthrough Therapy; Orphan Drug; RMAT

Apr-Jun 2024

insulin lispro (biosimilar to Eli Lilly’s Humalog)

Gan & Lee/Sandoz

T1DM; T2DM

BLA

04/01/2024

apomorphine infusion device

Supernus

Parkinson’s disease

NDA

04/09/2024

insulin aspart (biosimilar to Novo Nordisk’s Novolog)

Gan & Lee/Sandoz

T1DM; T2DM

BLA

04/14/2024

ranibizumab (biosimilar to Genentech’s Lucentis)

STADA Arzneimittel/ Xbrane

Diabetic retinopathy; DME; Myopic choroidal neovascularization; Macular edema following RVO; Wet AMD

Intravitreal

BLA

04/21/2024

valbenazine (Ingrezza®) oral granules

Neurocrine Biosciences

Tardive dyskinesia; chorea associated with Huntington’s disease

Oral

NDA; Orphan Drug

04/30/2024

rituximab (biosimilar to Genentech’s Rituxan)

Dr. Reddy’s

CCL; Granulomatosis with polyangiitis/microscopic polyangiitis; NHL; Mature B-cell NHL/mature B-cell acute leukemia; Pemphigus vulgaris; RA

BLA

05/10/2024

camrelizumab

Jiangsu Hengrui

HCC (unresectable, 1stline, in combination with rivoceranib)

BLA; Orphan Drug

05/16/2024

rivoceranib

Elevar

HCC (unresectable, 1stline, in combination with camrelizumab)

Oral

NDA; Orphan Drug

05/16/2024

macitentan/tadalafil

Janssen

PAH (WHO functional class II-III)

Oral

NDA; Orphan Drug

05/30/2024

27 | MAGELLANRX.COM

PIPELINE DRUG LIST continued NAME

MANUFACTURER

DOSAGE FORM

CLINICAL USE

DEVELOPMENT STATUS

FDA DECISION

troriluzole

Biohaven

Spinocerebellar ataxia type 3

Oral

NDA; Fast Track; Orphan Drug

05/31/2024

imetelstat

Geron

Myelodysplastic syndrome (transfusiondependent, ESAineligible)

NDA; Fast Track; Orphan Drug

06/20/2024

ensifentrine

Verona

COPD

Inhaled

NDA

06/26/2024

cefepime/enmetazobactam Allecra

UTI (complicated)

NDA; Fast Track; QIDP

06/27/2024

aflibercept (biosimilar to Regeneron’s Eylea)

Celltrion

DME; Diabetic retinopathy; Macular edema following RVO; Wet AMD

Intravitreal

BLA

06/28/2024

aflibercept (biosimilar to Regeneron’s Eylea)

Coherus

DME; Diabetic retinopathy; Macular edema following RVO; Wet AMD

Intravitreal

BLA

06/28/2024

iptacopan

Novartis

PNH

Oral

NDA; Breakthrough Therapy; Orphan Drug

06/28/2024

immunoglobulin (human)

Biotest AG

Primary immunodeficiencies

BLA

06/29/2024

naloxone

Orexo

Opioid overdose

Intranasal

505(b)(2) NDA

Jul-Sep 2024

vonoprazan

Phathom

Non-erosive GERD

Oral

NDA

Jul-Sep 2024

tislelizumab

Beigene

Esophageal squamous cell carcinoma (unresectable, recurrent, locally advanced, or metastatic, 1st-line)

BLA; Orphan Drug

Jul-Dec 2024

crovalimab

Genentech

PNH

IV, SC

BLA; Breakthrough Therapy; Orphan Drug

07/27/2024

danicopan

AstraZeneca

PNH

Oral

NDA; Breakthrough Therapy; Orphan Drug

07/27/2024

sotatercept

Merck/BristolMyers Squibb

PAH

NDA; Breakthrough Therapy; Orphan Drug

08/01/2024

mavorixafor

Warts, Oral hypogammaglobulinemia, infections, and myelokathexis (WHIM) syndrome (ages ≥ 12 years)

NDA; Breakthrough Therapy; Fast Track; Orphan Drug; RPD

09/05/2024

tovorafenib

Day One Bio

Glioma (relapsed/ progressive, low-grade, monotherapy)

Oral

NDA; Breakthrough Therapy; Orphan Drug; RPD

09/11/2024

prademagene zamikeracel (EB-101)

Abeona

Epidermolysis bullosa (recessive dystrophic)

Surgical application

BLA; Breakthrough Therapy; Orphan Drug; RMAT

09/26/2024

galantamine

Alpha Cognition

Alzheimer’s disease (mild to moderate)

Oral

505(b)(2) NDA

09/27/2024

xanomeline/trospium

Karuna

Schizophrenia

Oral

NDA

09/28/2024

deuruxolitinib

Sun

Alopecia areata (severe)

Oral

NDA; Breakthrough Therapy; Fast Track

10/04/2024

28 | MAGELLANRX.COM

PIPELINE DRUG LIST continued NAME

MANUFACTURER

DOSAGE FORM

CLINICAL USE

aflibercept (biosimilar to Regeneron’s Eylea)

Biocon/Janssen

DME; Diabetic retinopathy; Macular edema following RVO; Wet AMD

atezolizumab SC

Genentech

bevacizumab (biosimilar to Genentech’s Avastin)

Intravitreal

DEVELOPMENT STATUS

FDA DECISION

BLA

Pending

Hepatocellular carcinoma; SC Melanoma (BRAF-mutant); NSCLC; SCLC; Soft tissue sarcoma; Urothelial cancer

BLA

Pending

Bio-Thera Solutions/Sandoz

Brain cancer; Cervical cancer; CRC; NSCLC; Ovarian cancer; RCC

BLA

Pending

bevacizumab (biosimilar to Genentech’s Avastin)

Centus

Brain cancer; Cervical cancer; CRC; NSCLC; Ovarian cancer; RCC

BLA

Pending

exenatide SC mini-pump

Intarcia

T2DM

NDA

Pending

filgrastim (biosimilar to Amgen’s Neupogen)

Apotex

Neutropenia/leukopenia

IV, SC

BLA

Pending

natalizumab (biosimilar to Biogen’s Tysabri)

Polpharma/Sandoz MS; CD

BLA

Pending

pegfilgrastim (biosimilar to Amgen’s Neulasta)

Apotex

Neutropenia/leukopenia

BLA

Pending

pegfilgrastim (biosimilar to Amgen’s Neulasta)

Lupin

Neutropenia/leukopenia

BLA

Pending

tocilizumab (biosimilar to Genentech’s Actemra)

Fresenius Kabi

RA; Polyarticular JIA; Systemic JIA

IV, SC

BLA

Pending

toripalimab

Coherus

Nasopharyngeal cancer (advanced recurrent/ metastatic, 1st-line with gemcitabine & cisplatin, subsequent monotherapy)

BLA; Breakthrough Therapy; Orphan Drug

Pending

Submitted (Supplementals) enzalutamide (Xtandi®)

Astellas/Pfizer

Prostate cancer (nonmetastatic, castrationsensitive, with high-risk biochemical recurrence)

Oral

sNDA; Fast Track; Priority Review

Oct-Dec 2023

pegfilgrastim-cbqv onbody injector (Udenyca OBI)(biosimilar to Neulasta Onpro)

Coherus

Neutropenia/leukopenia

sBLA

Oct-Dec 2023

secukinumab (Cosentyx®)

Novartis

Hidradenitis suppurativa

sNDA

Oct-Dec 2023

bupivacaine liposome (Exparel®)

Pacira

Postsurgical pain (singledose sciatic nerve block in the popliteal fossa as well as femoral nerve block in the adductor canal)

sNDA

11/13/2023

isavuconazonium sulfate (Cresemba®)

Astellas

Aspergillosis or mucormycosis (invasive; ages 1-17 years)

IV, Oral

sNDA; Orphan Drug

12/08/2023

dasiglucagon (Zegalogue®)

Novo Nordisk

Congenital hyperinsulinemia (pediatric patients ages ≥ 7 days)

sNDA; Orphan Drug; Priority Review

12/10/2023

29 | MAGELLANRX.COM

PIPELINE DRUG LIST continued NAME

MANUFACTURER

DOSAGE FORM

CLINICAL USE

DEVELOPMENT STATUS

FDA DECISION

fluticasone propionate (Xhance®)

Optinose

Chronic rhinosinusitis

Intranasal

sNDA

12/16/2023

idecabtagene vicleucel (Abecma®)

Bristol-Myers Squibb

Multiple myeloma (R/R, prior immunomodulatory, proteasome inhibitor, and anti-CD38 therapy)

sBLA; Breakthrough Therapy; Orphan Drug

12/16/2023

pembrolizumab (Keytruda®) Merck

Gastric and gastroesophageal junction adenocarcinoma (locally advanced unresectable or metastatic, 1st-line, in combination with fluoropyrimidine & platinum chemotherapy)

sBLA; Orphan Drug

12/16/2023

budesonide (Tarpeyo®)

Calliditas

Immunoglobulin A (IgA) nephropathy (Berger’s disease)

Oral

sNDA; Orphan Drug; Priority Review

12/20/2023

von Willebrand factor/ coagulation factor VIII complex (lyophilized powder) (Wilate®)

Octapharma

von Willebrand disease (routine prophylaxis)

sBLA

12/23/2023

sotorasib (Lumakras®)

Amgen

NSCLC (locally advanced Oral or metastatic, KRAS G12Cmutated; ≥ 2-line)

sNDA; Breakthrough Therapy; Fast Track; Orphan Drug

12/24/2023

influenza vaccine, live (FluMist Quadrivalent)

AstraZeneca

Seasonal influenza prevention (self-/ caregiver-administered)

Intranasal

sBLA

Jan-Mar 2024

osimertinib (Tagrisso®)

AstraZeneca

NSCLC (locally advanced or metastatic, EGFRmutated, in combination with chemotherapy)

Oral

sNDA; Breakthrough Therapy; Fast Track; Orphan Drug; Priority Review

Jan-Mar 2024

zanubrutinib (Brukinsa®)

Beigene

Follicular lymphoma (R/R, Oral ≥ 3rd-line, in combination with obinutuzumab)

sNDA; Fast Track

Jan-Mar 2024

belzutifan (Welireg™)

Merck

RCC (advanced, following immune checkpoint and antiangiogenic therapies)

Oral

sNDA; Breakthrough Therapy; Orphan Drug; Priority Review

01/17/2024

pembrolizumab (Keytruda)

Merck

Cervical cancer (in combination with chemoradiotherapy)

sBLA; Priority Review

01/19/2024

tesamorelin (Egrifta®) (high concentration)

Theratechnologies

HIV lipodystrophy

sBLA

01/22/2024

bupivacaine/meloxicam (Zynrelef®)

Heron

Postsurgical pain (soft tissue and orthopedic surgical procedures)

Instillation

sNDA; Breakthrough Therapy; Fast Track

01/23/2024

treprostinil powder (Yutrepia™)

Liquidia/ GlaxoSmithKline

Pulmonary hypertension associated with interstitial lung disease

Inhaled

505(b)(2) NDA

01/24/2024

dupilumab (Dupixent®)

Sanofi/Regeneron

Eosinophilic esophagitis (ages 1-11 years)

sBLA; Breakthrough Therapy; Orphan Drug; Priority Review

01/31/2024

30 | MAGELLANRX.COM

PIPELINE DRUG LIST continued NAME

MANUFACTURER

DOSAGE FORM

CLINICAL USE

DEVELOPMENT STATUS

FDA DECISION

coagulation factor IX, recombinant (Ixinity®)

Pediapharm

Hemophilia B (ondemand, prophylactic, and perioperative treatment, ages < 12 years)

sBLA

Feb-Mar 2024

pembrolizumab (Keytruda)

Merck

Biliary tract cancer (locally advanced unresectable or metastatic, in combination with chemotherapy)

sBLA

02/07/2024

irinotecan liposomal (Onivyde®)

Ipsen

Pancreatic cancer IV (metastatic ductal adenocarcinoma, 1stline, in combination with 5-fluorouracil/leucovorin/ oxaliplatin)

sNDA; Fast Track; Orphan Drug

02/13/2024

nintedanib (Ofev®)

Boehringer Ingelheim

Fibrosing interstitial lung disease (ages 6-17 years)

Oral

sNDA; Breakthrough Therapy

Mar-Apr 2024

faricimab-svoa (Vabysmo®)

Genentech

Macular edema following RVO

Intravitreal

sBLA

03/09/2024

maralixibat (Livmarli®)

Mirum

Progressive familial intrahepatic cholestasisrelated pruritus (ages ≥ 2 months)

Oral

sNDA; Breakthrough Therapy; Orphan Drug

03/13/2024

bempedoic acid (Nexletol®)

Esperion

CV risk reduction

Oral

sNDA

04/01/2024

bempedoic acid/ezetimibe (Nexlizet®)

Esperion

CV risk reduction

Oral

sNDA

04/01/2024

ciltacabtagene autoleucel (Carvykti®)

Janssen

Multiple myeloma (R/R, as IV earlier treatment)

sBLA; Breakthrough Therapy; Orphan Drug

04/05/2024

diazepam buccal film (Libervant™)

Aquestive

Seizure disorders (ages 2-5 years)

Oral Transmucosal

505(b)(2) NDA; Fast Track; Orphan Drug

04/26/2024

hepatitis B vaccine (Heplisav-B®)

Dynavax

Hepatitis B prevention (adults on hemodialysis)

sBLA

05/13/2024

fam-trastuzumab deruxtecan-nxki (Enhertu®)

Daiichi Sankyo

Breast cancer (HER2+, 3rd-line)

sBLA; Breakthrough Therapy

05/27/2024

immunoglobulin (human) 10% (Gammagard)

Takeda

Chronic inflammatory demyelinating polyneuropathy

sBLA

05/27/2024

rilpivirine (Edurant®)

Janssen

HIV-1 treatment (children weighing ≥ 10 kg)

Oral

sNDA

05/28/2024

vedolizumab (Entyvio®)

Takeda

CD (SC maintenance following IV induction)

sBLA

Jun-Jul 2024

amivantamab-vmjw (Rybrevant®)

Janssen

NSCLC (locally advanced or metastatic, in combination with carboplatin-pemetrexed, 1st-line)

sBLA; Breakthrough Therapy; RTOR

06/25/2024

risankizumab-rzaa (Skyrizi®) Abbvie

IV, SC

sBLA

06/28/2024

roflumilast (Zoryve™)

Arcutis

Atopic dermatitis (adults and pediatrics ages ≥ 6 years)

Topical

sNDA

07/12/2024

adalimumab-aaty (Yuflyma) (biosimilar to Humira)

Celltrion

RA; AS; PSO; PsA; JIA; CD; UC

sBLA for interchangeability

Oct-Dec 2024

31 | MAGELLANRX.COM

PIPELINE DRUG LIST continued Phase 3 (New Drugs) AAV8-ranibizumab

Regenxbio

DME; Wet-AMD

abelacimab

Anthos

abiraterone

BLA; Orphan Drug

TBD

Stroke prevention in atrial SC fibrillation; VTE

BLA; Fast Track

TBD

Tavanta

Prostate cancer

Oral

NDA

TBD

acoramidis

Bridgebio

Transthyretin amyloid cardiomyopathy; Transthyretin amyloid polyneuropathy

Oral

NDA; Orphan Drug

TBD

adagrasib

Mirati

CRC

Oral

NDA; Breakthrough Therapy

TBD

adintrevimab

Invivyd

COVID-19

BLA

TBD

aficamten

Cytokinetics

Hypertrophic cardiomyopathy

Oral

NDA; Breakthrough Therapy; Orphan Drug

TBD

aflibercept (biosimilar to Regeneron’s Eylea)

Amgen

DME; Wet-AMD

Intravitreal

BLA

TBD

aflibercept (biosimilar to Regeneron’s Eylea)

SamChunDang

DME; Wet-AMD

Intravitreal

BLA

TBD

aflibercept (biosimilar to Regeneron’s Eylea)

Samsung Bioepis

DME; Wet-AMD

Intravitreal

BLA

TBD

aflibercept (biosimilar to Regeneron’s Eylea)

Sandoz

DME; Wet-AMD

Intravitreal

BLA

TBD

AL-001

Alector

Frontotemporal dementia

BLA

TBD

ALXN1720

AstraZeneca

Myasthenia gravis

BLA

TBD

Anti-betv1 antibody (REGN-5713-5714-5715)

Regeneron

Birch allergy

BLA

TBD

ANX-005

Annexon

Guillain-Barré syndrome

BLA; Fast Track; Orphan Drug

TBD

apitegromab

Scholar Rock

Spinal muscular atrophy

BLA; Fast Track; Orphan Drug

TBD

AR-15512

Aerie

DED

Ophthalmic

NDA

TBD

aramchol

Galmed

NASH

Oral

NDA

TBD

arimoclomol

Zevra

Niemann-Pick disease

Oral

NDA; Breakthrough Therapy; Fast Track; Orphan Drug; RPD

TBD

ARO-APOC3

Arrowhead

Familial chylomicronemia syndrome

NDA; Fast Track; Orphan Drug

TBD

astegolimab

Genentech

COPD

BLA

TBD

asundexian

Bayer

Stroke prevention in atrial Oral fibrillation

NDA; Fast Track

TBD

atezolizumab (Tecentriq®)

Genentech

Breast cancer (TNBC)

BLA

TBD

autologous kidney cells (ReACT)

Prokidney

CKD

Renal cortex injection

BLA; RMAT

TBD

aztreonam-avibactam

Abbvie

Intra-abdominal bacterial infections

NDA; Fast Track; QIDP

TBD

baclofen/naltrexone/ sorbitol

Pharnext

Charcot-Marie-Tooth disease

Oral

NDA; Fast Track; Orphan Drug

TBD

bamlanivimab

Eli Lilly

COVID-19

BLA

TBD

batiraxcept

Aravive

Ovarian cancer

BLA; Fast Track

TBD

bemnifosbuvir

Atea

COVID-19

Oral

NDA; Fast Track

TBD

bentracimab

SERB

Ticagrelor (Brilinta ) reversal

BLA; Breakthrough Therapy

TBD

32 | MAGELLANRX.COM

Subretinal

PIPELINE DRUG LIST continued NAME

MANUFACTURER

DOSAGE FORM

CLINICAL USE

DEVELOPMENT STATUS

FDA DECISION

bevacizumab (biosimilar to Genentech’s Avastin)

Essex

DME; Wet-AMD

BLA

TBD

bimekizumab

UCB

Axial spondyloarthritis; Hidradenitis suppurativa; PSO

BLA

TBD

blarcamesine

Anavex Life Sciences

Alzheimer’s disease; Rett syndrome

Oral

NDA; Fast Track; Orphan Drug

TBD

botaretigene sparoparvovec

Janssen

Retinitis pigmentosa

Subretinal

BLA; Fast Track; Orphan Drug

TBD

BPR277

Lifemax

Netherton syndrome

Topical

NDA; Fast Track; Orphan Drug; RPD

TBD

brensocatib

Insmed/ AstraZeneca

Bronchiectasis

Oral

NDA; Breakthrough Therapy

TBD

cagrilintide/semaglutide

Novo Nordisk

T2DM; Obesity/ overweight

NDA

TBD

cannabidiol gel

Zynerba

Fragile X syndrome

Topical

NDA; Fast Track; Orphan Drug

TBD

CAP-1002 (allogeneic adult Nippon Shinyaku stem cells)

DMD

BLA; Orphan Drug; RMAT TBD

carbachol/brimonidine

Visus

Presbyopia

Ophthalmic

505(b)(2) NDA

TBD

cemdisiran

Alnylam

Myasthenia gravis

NDA; Orphan Drug

TBD

cenerimod

Idorsia

SLE

Oral

NDA; Fast Track

TBD

cetuximab sarotalocan

Rakuten Medical

SCCHN

BLA; Fast Track

TBD

chikungunya vaccine

Bavarian Nordic

Chikungunya virus prevention

BLA; Fast Track

TBD

clesrovimab

Merck

RSV prevention

BLA

TBD

cobitolimod

Index/Merck

Rectal

NDA; Orphan Drug

TBD

colistimethate sodium

Zambon

Bronchiectasis

Inhaled

NDA; Breakthrough Therapy; Fast Track; QIDP

TBD

condoliase

Ferring

Sciatica

Intrathecal

BLA

TBD

copper histidine

Zydus

Menkes disease

NDA; Breakthrough Therapy; Fast Track; Orphan Drug; RPD

TBD

crinecerfont

Neurocrine

Congenital adrenal hyperplasia

Oral

NDA; Orphan Drug

TBD

crovalimab

Genentech

Hemolytic uremic syndrome

IV, SC

BLA

TBD

CTX-009

Compass

Biliary tract cancer

BLA

TBD

cytisinicline

Achieve Life Sciences

Smoking cessation

Oral

NDA

TBD

dabocemagene autoficel

Castle Creek

Epidermolysis bullosa

Intradermal

BLA; Fast Track; Orphan Drug; RMAT

TBD

darvadstrocel

Takeda

Perianal fistulas

BLA; Orphan Drug

TBD

datopotamab deruxtecan

Daiichi Sankyo

Breast cancer; NSCLC

BLA

TBD

debamestrocel

Brainstorm

ALS

Intrathecal

NDA; Fast Track; Orphan Drug

TBD

dengue tetravalent vaccine, live, attenuated

Takeda

Dengue fever (ages 4-60 years)

BLA; Fast Track

TBD

denosumab (Biosimilar to Amgen’s Prolia/Xgeva)

Biocon

Osteoporosis/osteopenia

BLA

TBD

33 | MAGELLANRX.COM

PIPELINE DRUG LIST continued NAME

MANUFACTURER

DOSAGE FORM

CLINICAL USE

DEVELOPMENT STATUS

FDA DECISION

denosumab (Biosimilar to Amgen’s Prolia/Xgeva)

Celltrion

Osteoporosis/osteopenia

BLA

TBD

denosumab (Biosimilar to Amgen’s Prolia/Xgeva)

Gedeon Richter

Osteoporosis/osteopenia

BLA

TBD

denosumab (Biosimilar to Amgen’s Prolia/Xgeva)

Teva

Osteoporosis/osteopenia

BLA

TBD

deoxythymidine and deoxycytidine

UCB

Thymidine kinase 2 (TK2) deficiency

Oral

BLA; Breakthrough Therapy; Orphan Drug

TBD

difamilast

Medimetriks

Atopic dermatitis

Topical

NDA

TBD

difelikefalin

Cara

Atopic dermatitis; Pruritus Oral

NDA

TBD

dinutuximab beta

EUSA

Neuroendocrine tumors

BLA; Orphan Drug

TBD

dirloctocogene samoparvovec

Genentech

Hemophilia A

BLA; Breakthrough Therapy; Orphan Drug

TBD

donaperminogene seltoplasmid

Helixmith

Diabetic foot ulcers (chronic non-healing)

BLA

TBD

doravirine/islatravir

Merck

HIV-1 infection treatment

Oral

NDA

TBD

dust mite immunotherapy tablet

Stallergenes Greer

Allergic rhinitis

BLA

TBD

ebselen

Sound

Meniere’s disease

Oral

NDA; Fast Track

TBD

efzofitimod

Atyr

Sarcoidosis

BLA; Fast Track; Orphan Drug

TBD

elafibranor

Genfit

Primary biliary cholangitis Oral

NDA; Breakthrough Therapy; Orphan Drug

TBD

emcitate

Rare Thyroid Therapeutics

Monocarboxylate transporter 8 (MCT8) deficiency

Oral

NDA; Fast Track; Orphan Drug; RPD

TBD

enmetazobactam

Allecra

UTI (complicated)

NDA; Fast Track; QIDP

TBD

eplontersen

Ionis/AstraZeneca

Transthyretin amyloid cardiomyopathy (ATTR-CM, wild-type or hereditary)

NDA; Orphan Drug

TBD

esreboxetine

Axsome

Fibromyalgia

Oral

NDA

TBD

estetrol

Mithra

Menopausal vasomotor symptoms

Oral

NDA

TBD

etavopivat

Novo Nordisk

SCD

Oral

NDA; Fast Track; Orphan Drug; RPD

TBD

etrasimod

Pfizer

Atopic dermatitis; CD

Oral

NDA

TBD

etripamil

Milestone

Supraventricular tachycardia

Intranasal

NDA

TBD

evobrutinib

Merck

Oral

NDA

TBD

factor VIII mimetic bispecific antibody

Novo Nordisk

Hemophilia A

BLA; Orphan Drug

TBD

fasedienol

Vistagen

Social anxiety disorder

Intranasal

NDA; Fast Track

TBD

fenebrutinib

Genentech

Oral

NDA

TBD

fianlimab

Regeneron

Melanoma

BLA

TBD

filgotinib

Gilead

Oral

NDA

TBD

fitusiran

Sanofi

Hemophilia A and B

NDA; Fast Track; Orphan Drug

TBD

garadacimab

CSL

HAE

BLA; Fast Track; Orphan Drug

TBD

34 | MAGELLANRX.COM

PIPELINE DRUG LIST continued NAME

MANUFACTURER

DOSAGE FORM

CLINICAL USE

DEVELOPMENT STATUS

FDA DECISION

gavorestat

Applied

Galactosemia; Sorbitol dehydrogenase deficiency

Oral

NDA; Fast Track; Orphan Drug; RPD

TBD

GBT601

Pfizer

SCD

Oral

NDA; Orphan Drug

TBD

gepotidacin

GlaxoSmithKline

UTI (uncomplicated)

Oral

NDA; QIDP

TBD

giredestrant

Genentech

Breast cancer (HR+/ HER2-)

Oral

NDA; Fast Track

TBD

giroctocogene fitelparvovec

Pfizer

Hemophilia A

BLA; Fast Track; Orphan Drug; RMAT

TBD

glepaglutide

Zealand

Short bowel syndrome

NDA; Orphan Drug

TBD

gold nanocrystal

Clene

ALS

Oral

NDA; Orphan Drug

TBD

granexin

Xequel

Surgical scar formation reduction

Topical

NDA

TBD

ianalumab

Novartis

Autoimmune hemolytic anemia; Lupus nephritis; SLE; Sjogren’s syndrome

BLA; Fast Track

TBD

imsidolimab

Anaptysbio

Generalized pustular psoriasis

IV, SC

BLA; Orphan Drug

TBD

inavolisib

Genentech

Breast cancer (HR+/HER2-, 1st-line)

Oral

NDA

TBD

inclacumab

Pfizer

SCD

BLA; Orphan Drug

TBD

infliximab (biosimilar to Janssen’s Remicade)

Nichi-Iko

RA; AS; PSO; CD

BLA

TBD

influenza nanoparticle vaccine

Novavax

Seasonal influenza prevention

BLA; Fast Track

TBD

insulin aspart (biosimilar to Novo Nordisk’s Novolog)

Amphastar

T1DM; T2DM

BLA

TBD

insulin aspart (biosimilar to Novo Nordisk’s Novolog)

Sanofi

T1DM; T2DM

BLA

TBD

insulin glargine (biosimilar to Sanofi-Aventis’ Lantus)

Genesys

T1DM; T2DM

BLA

TBD

iptacopan

Novartis

C3 glomerulopathy; Hemolytic uremic syndrome; Immunoglobulin A nephropathy (Berger’s disease); PNH

Oral

NDA; Breakthrough Therapy; Orphan Drug; RPD

TBD

isotretinoin

Timber

Congenital ichthyosis

Topical

505(b)(2) NDA; Breakthrough Therapy

TBD

itepekimab

Regeneron

COPD

BLA; Fast Track

TBD

ivarmacitinib

Reistone

Oral

NDA

TBD

izokibep

Affibody

Hidradenitis suppurativa

BLA

TBD

JDQ-443

Novartis

NSCLC

Oral

NDA

TBD

Lactobacillus reuteri

Infant Bacterial Therapeutics

Necrotizing enterocolitis

Oral

BLA; Orphan Drug; RPD

TBD

lanifibranor

Inventiva

NASH

Oral

NDA; Breakthrough Therapy; Fast Track

TBD

lazertinib

Genosco/Janssen

NSCLC

Oral

NDA

TBD

lenadogene nolparvovec

Gensight

Leber’s hereditary optic neuropathy

Intravitreal

BLA; Orphan Drug

TBD

35 | MAGELLANRX.COM

PIPELINE DRUG LIST continued NAME

MANUFACTURER

DOSAGE FORM

CLINICAL USE

DEVELOPMENT STATUS

FDA DECISION

leriglitazone

Minoryx

Adrenoleukodystrophy

Oral

NDA; Fast Track; Orphan Drug

TBD

lerodalcibep

LIB

Dyslipidemia/ hypercholesterolemia

BLA

TBD

levodopa/carbidopa patch pump

Mitsubishi Tanabe

Parkinson’s disease

505(b)(2) NDA

TBD

ligelizumab

Novartis

Food allergies

BLA

TBD

linerixibat

GlaxoSmithKline

Cholestatic pruritus

Oral

NDA; Orphan Drug

TBD

litifilimab

Biogen

SLE

BLA

TBD

Lyme disease vaccine

Valneva/Pfizer

Lyme immunization

BLA; Fast Track

TBD

marstacimab

Pfizer

Hemophilia A and B

IV, SC

BLA; Fast Track; Orphan Drug

TBD

marzeptacog alfa

Catalyst

Hemophilia A and B (with inhibitors)

BLA; Fast Track; Orphan Drug

TBD

masitinib

AB Science

ALS; Asthma

Oral

NDA; Orphan Drug

TBD

mavodelpar

Reneo

Primary mitochondrial myopathies

Oral

NDA; Fast Track; Orphan Drug

TBD

meningococcal vaccine (GSK3536819A)

GlaxoSmithKline

Meningococcal immunization

BLA

TBD

midomafetamine

Multidisciplinary Association for Psychedelic Studies

PTSD

Oral

NDA; Breakthrough Therapy

TBD

mirikizumab

Eli Lilly

IV, SC

BLA

TBD

molnupiravir (Lagevrio)

Merck

COVID-19

Oral

NDA

TBD

mometasone furoate implant

Lyra

Chronic rhinosinusitis

Nasal implant

505(b)(2) NDA

TBD

MTX-005 (anti-BK polyomavirus antibody)

Memo

BK polyomavirus IV infection (renal transplant recipients)

BLA; Fast Track

TBD

nalbuphine ER

Trevi

Pruritus

Oral

NDA; Fast Track

TBD

narsoplimab

Omeros

Hemolytic uremic syndrome

IV, SC

BLA; Fast Track

TBD

navitoclax

Abbvie

Myelofibrosis

Oral

NDA; Orphan Drug

TBD

nemolizumab

Galderma

Atopic dermatitis; Pruritus SC

BLA; Breakthrough Therapy

TBD

nipocalimab

Janssen

Autoimmune hemolytic anemia; Myasthenia gravis

BLA; Fast Track; Orphan Drug

TBD

nomacopan

Akari

HSCT-associated thrombotic microangiopathy; PNH

BLA; Fast Track; Orphan Drug; RPD

TBD

NPC-12Y

Nobelpharma

Tuberous sclerosis complex skin lesions

Topical

NDA

TBD

obefazimod

Abivax

Oral

NDA

TBD

obicetrapib

NewAmsterdam

Dyslipidemia/ hypercholesterolemia

Oral

NDA

TBD

olezarsen

Akcea

Dyslipidemia/ hypercholesterolemia; Familial chylomicronemia syndrome

NDA; Fast Track

TBD

36 | MAGELLANRX.COM

PIPELINE DRUG LIST continued NAME

MANUFACTURER

DOSAGE FORM

CLINICAL USE

DEVELOPMENT STATUS

FDA DECISION

olokizumab

R-Pharm

BLA

TBD

olorofim

F2G Ltd

Fungal infections (systemic)

IV, Oral

NDA; Breakthrough Therapy; Orphan Drug; QIDP

TBD

omalizumab (biosimilar to Genentech’s Xolair®)

Kashiv

Asthma; Nasal polyps; Urticaria

BLA

TBD

omalizumab (biosimilar to Genentech’s Xolair)

Teva

Asthma; Nasal polyps; Urticaria

BLA

TBD

orforglipron

Eli Lilly

Obesity/overweight

Oral

NDA

TBD

paltusotine

Corcept

Acromegaly

Oral

NDA; Orphan Drug

TBD

pamrevlumab

Fibrogen

DMD

BLA; Fast Track; Orphan Drug; RPD

TBD

paromomycin

Appili

Leishmaniasis

Topical

NDA; Orphan Drug

TBD

parsaclisib

Incyte

Autoimmune hemolytic anemia

Oral

NDA; Orphan Drug

TBD

patritumab deruxtecan

Daiichi Sankyo

NSCLC

BLA; Breakthrough Therapy

TBD

pegadricase

Swedish Orphan Biovitrum

Gout

BLA

TBD

pelacarsen

Novartis

Dyslipidemia/ hypercholesterolemia

NDA; Fast Track

TBD

PHVS416

Pharvaris

HAE

Oral

NDA

TBD

piclidenoson

Can-Fite

PSO

Oral

NDA

TBD

PL-9643

Palatin

DED

Ophthalmic

NDA

TBD

plinabulin

Beyondspring

Chemotherapy-induced neutropenia prevention

NDA; Breakthrough Therapy

TBD

pneumococcal polyvalent conjugate vaccine (V116)

Merck

Pneumococcal disease prevention

BLA; Breakthrough Therapy

TBD

pollinex quattro

Allergy Therapeutics

Allergic rhinitis

BLA

TBD

pollinex quattro grass

Allergy Therapeutics

Allergic rhinitis

BLA

TBD

posoleucel

Allovir

Virus-associated hemorrhagic cystitis (post allogeneic HSCT)

BLA; Orphan Drug; RMAT TBD

povorcitinib

Incyte

Hidradenitis suppurativa

Oral

NDA

TBD

pozelimab

Regeneron

PNH

IV, SC

BLA; Orphan Drug

TBD

pritelivir

AiCuris Antiinfective Cures

Herpes simplex virus treatment

Oral

NDA; Breakthrough Therapy; Fast Track

TBD

pruxelutamide

Kintor

COVID-19

Oral

NDA

TBD

QRX003

Quoin

Netherton syndrome

Topical

NDA

TBD

relacorilant

Corcept

Cushing’s syndrome

Oral

NDA; Orphan Drug

TBD

remibrutinib

Novartis

MS; Urticaria

Oral

NDA

TBD

reparixin

Dompé

Transplant rejection

NDA; Orphan Drug

TBD

reproxalap

Aldeyra

Allergic conjunctivitis

Ophthalmic

NDA

TBD

resiniferatoxin

Grunenthal

Osteoarthritis pain (knee)

Intraarticular

NDA; Breakthrough Therapy

TBD

retatrutide

Eli Lilly

Obesity/overweight

BLA

TBD

RGX-121 (gene therapy)

Regenxbio

Mucopolysaccharidosis II (Hunter syndrome)

CNS injection

BLA; Fast Track; Orphan Drug; RPD; RMAT

TBD

37 | MAGELLANRX.COM

PIPELINE DRUG LIST continued NAME

MANUFACTURER

DOSAGE FORM

CLINICAL USE

DEVELOPMENT STATUS

FDA DECISION

rilzabrutinib

Sanofi

ITP

Oral

NDA; Fast Track; Orphan Drug

TBD

ritlecitinib

Pfizer

Vitiligo

Oral

NDA

TBD

rocatinlimab

Amgen

Atopic dermatitis

BLA

TBD

roflumilast foam

Arcutis

PSO

Topical

NDA

TBD

roxadustat

AstraZeneca

Anemia due to cytotoxic chemotherapy

Oral

NDA

TBD

rusfertide

Protagonist

Polycythemia vera

NDA; Fast Track; Orphan Drug

TBD

sabatolimab

Novartis

Myelodysplastic syndrome

BLA; Fast Track

TBD

sabizabulin

Veru

COVID-19

Oral

NDA; Fast Track

TBD

saroglitazar

Zydus

Primary biliary cholangitis Oral

NDA; Fast Track; Orphan Drug

TBD

sebetralstat

Kalvista

HAE

NDA; Fast Track; Orphan Drug

TBD

seladelpar

Cymabay

Primary biliary cholangitis Oral

NDA; Breakthrough Therapy; Orphan Drug

TBD

seltorexant

Janssen

MDD with insomnia

Oral

NDA

TBD

semaglutide

Novo Nordisk/ Gilead

NASH

NDA; Breakthrough Therapy

TBD

sepiapterin

PTC

Phenylketonuria (PKU)

Oral

NDA; Orphan Drug

TBD

serplulimab

Henlius

SCLC

BLA; Orphan Drug

TBD

soticlestat

Takeda

Dravet syndrome; Lennox-Gastaut syndrome

Oral

NDA; Orphan Drug

TBD

sotrovimab

Vir

COVID-19

BLA

TBD

sozinibercept

Opthea

Wet AMD

Intravitreal

BLA; Fast Track

TBD

sulopenem etzadroxil/ probenicid

Iterum

UTI (uncomplicated)

Oral

NDA; Fast Track; QIDP

TBD

survodutide

Boehringer Ingelheim

T2DM; Obesity/ overweight

NDA

TBD

tabelecleucel

Atara

Epstein-Barr virus-associated post-transplant lymphoproliferative disease

BLA; Breakthrough Therapy; Orphan Drug

TBD

tamibarotene

Syros

Myelodysplastic syndrome

Oral

NDA; Fast Track; Orphan Drug

TBD

tebipenem pivoxil

GlaxoSmithKline

UTI (complicated)

Oral

NDA; Fast Track; QIDP

TBD

telisotuzumab vedotin

Abbvie

NSCLC

BLA; Breakthrough Therapy

TBD

telitacicept

Rongchang

SLE

BLA; Fast Track

TBD

tiragolumab

Genentech

Esophageal cancer; NSCLC

BLA; Breakthrough Therapy; Orphan Drug

TBD

tolebrutinib

Sanofi

Oral

NDA

TBD

tradipitant

Vanda

Atopic dermatitis; COVID-19; Gastroparesis; Motion sickness

Oral

NDA

TBD

tramiprosate

Alzheon

Alzheimer’s disease

Oral

NDA; Fast Track

TBD

38 | MAGELLANRX.COM

Oral

PIPELINE DRUG LIST continued NAME

MANUFACTURER

DOSAGE FORM

CLINICAL USE

DEVELOPMENT STATUS

FDA DECISION

treosulfan

Medac

Allogenic-HSCT conditioning

NDA; Orphan Drug

TBD

tusamitamab ravtansine

Sanofi

NSCLC (2nd/3rd-line)

BLA

TBD

ulotaront

Concert

Schizophrenia

Oral

NDA; Breakthrough Therapy

TBD

upifitamab rilsodotin

Mersana

Ovarian cancer

BLA; Fast Track

TBD

ustekinumab (biosimilar to Janssen’s Stelara®)

Amgen

PSO

IV, SC

BLA

TBD

ustekinumab (biosimilar to Janssen’s Stelara)

Formycon

PSO

IV, SC

BLA

TBD

ustekinumab (biosimilar to Janssen’s Stelara)

Hikma

PSO

IV, SC

BLA

TBD

ustekinumab (biosimilar to Janssen’s Stelara)

Intas

PSO

IV, SC

BLA

TBD

vanzacaftor/tezacaftor/ deutivacaftor

Vertex

Oral

NDA; Orphan Drug

TBD

venglustat

Sanofi

Gaucher’s disease; GM2 gangliosidoses

Oral

NDA; Orphan Drug

TBD

viaskin peanut

DBV

Peanut allergy

Transdermal

BLA; Breakthrough Therapy; Fast Track

TBD

visomitin (SkQ1)

Mitotech

DED

Ophthalmic

NDA

TBD

von Willebrand factor concentrate

LFB

von Willebrand disease

BLA; Orphan Drug

TBD

zanidatamab

Jazz

Gastric cancer

BLA; Fast Track; Orphan Drug

TBD

zoliflodacin

Innoviva

Gonorrhea

Oral

NDA; Fast Track; QIDP

TBD

Phase 3 (Supplementals) alpelisib (Piqray®)

Novartis

Breast cancer (HER2+); Ovarian cancer

Oral

sNDA

TBD

atezolizumab (Tecentriq)

Genentech

SCCHN

sBLA

TBD

baricitinib (Olumiant®)

Eli Lilly

JIA

Oral

sNDA

TBD

benralizumab (Fasenra )

AstraZeneca

ANCA-associated vasculitis; Bullous pemphigoid; Chronic rhinosinusitis with nasal polyposis; Eosinophilic esophagitis

sBLA; Orphan Drug

TBD

brexpiprazole (Rexulti®)

Otsuka

PTSD

Oral

sNDA

TBD

brolucizumab-dbll (Beovu®)

Novartis

Diabetic retinopathy

Intravitreal

sBLA

TBD

Novartis

NSCLC (adjuvant)

sBLA

TBD

cemiplimab-rwlc (Libtayo )

Regeneron

Melanoma

sBLA

TBD

dupilumab (Dupixent)

Sanofi

Bullous pemphigoid; COPD

sBLA; Orphan Drug

TBD

durvalumab (Imfinzi®)

AstraZeneca

Bladder cancer (1st-line); Gastric cancer

sBLA; Breakthrough Therapy

TBD

efgartigimod (Vyvgart®)

Argenx

ITP

sBLA; Orphan Drug

TBD

ferric carboxymaltose (Injectafer®)

Daiichi Sankyo

Anemia in heart failure

sNDA

TBD

canakinumab (Ilaris®) ®

39 | MAGELLANRX.COM

PIPELINE DRUG LIST continued NAME

MANUFACTURER

DOSAGE FORM

CLINICAL USE

DEVELOPMENT STATUS

FDA DECISION

ferric derisomaltose (Monoferric®)

Pharmacosmos

Anemia in heart failure

sNDA

TBD

fostamatinib (Tavalisse®)

Rigel

Autoimmune hemolytic anemia

Oral

sNDA; Fast Track; Orphan Drug

TBD

guselkumab (Tremfya®)

Janssen

sBLA

TBD

ibrexafungerp (Brexafemme®)

GlaxoSmithKline

Fungal infections (systemic)

Oral

sNDA; Fast Track; Orphan Drug; QIDP

TBD

iloperidone (Fanapt®)

Vanda

Bipolar disorder

Oral

sNDA

TBD

inebilizumab-cdon (Uplizna®)

Horizon

IgG4-related disease; Myasthenia gravis

sBLA

TBD

lumateperone (Caplyta®)

Intra-Cellular Therapies

MDD

Oral

sNDA

TBD

mepolizumab (Nucala®)

GlaxoSmithKline

COPD

IV, SC

sBLA

TBD

meropenem/vaborbactam (Vabomere®)

Melinta

Bacteremia; HAP

sNDA; QIDP

TBD

mitapivat (Pyrukynd®)

Agios

SCD; Thalassemia (Alpha, Beta)

Oral

sNDA; Orphan Drug

TBD

mosunetuzumab-axgb (Lunsumio™)

Genentech

DLBCL

sBLA

TBD

obinutuzumab (Gazyva®)

Genentech

Lupus nephritis; SLE

sBLA; Breakthrough Therapy

TBD

omalizumab (Xolair)

Genentech

Food allergies

sBLA; Breakthrough Therapy

TBD

pegcetacoplan (Empaveli®)

Apellis

Autoimmune hemolytic anemia

sNDA; Orphan Drug

TBD

phentolamine 0.75% (RyzumviI™)

Ocuphire

Presbyopia; Dim light vision disturbances

Ophthalmic

sNDA

TBD

ranibizumab port delivery system (Susvimo®)

Genentech

Diabetic retinopathy: DME

Intravitreal

sBLA

TBD

rimegepant (Nurtec ODT®)

Pfizer

Chronic rhinosinusitis

Oral

sNDA

TBD

romiplostim (Nplate )

Amgen

Chemotherapy-induced thrombocytopenia

sBLA; Orphan Drug

TBD

satralizumab-mwge (Enspryng®)

Genentech

Myasthenia gravis; Myelin oligodendrocyte glycoprotein antibodyassociated disease

sBLA; Orphan Drug

TBD

secukinumab (Cosentyx)

Novartis

Giant cell arteritis; Lupus nephritis

sBLA

TBD

semaglutide (Rybelsus®)

Novo Nordisk

Obesity/overweight

Oral

sNDA

TBD

semaglutide (Wegovy )

Novo Nordisk

CVD; Chronic HFpEF

sNDA

TBD

sparsentan (Filspari )

Travere

Focal segmental glomerulosclerosis

Oral

sNDA; Orphan Drug

TBD

tapinarof (Vtama®)

Roivant

Atopic dermatitis

Topical

sNDA

TBD

tezepelumab-ekko (Tezspire®)

Amgen

Chronic rhinosinusitis with nasal polyposis

sBLA

TBD

vedolizumab (Entyvio)

Takeda

GVHD prophylaxis

sBLA; Orphan Drug

TBD

venetoclax (Venclexta )

Abbvie/ Genenetech

Multiple myeloma; Myelodysplastic syndrome

Oral

sNDA; Breakthrough Therapy; Orphan Drug

TBD

40 | MAGELLANRX.COM

PIPELINE DRUG LIST continued

Complete Response Letter (CRL) avasopasem manganese

Galera

Oral mucositis (severe, radiotherapy-induced, in patients with head & neck cancer)

CRL

TBD

bevacizumab-vikg

Outlook

Wet AMD

Intravitreal

CRL

TBD

denileukin diftitox

Citius

Cutaneous T-cell lymphoma (R/R)

CRL

TBD

epinephrine

ARS

Anaphylaxis

Intranasal

CRL

TBD

lebrikizumab

Eli Lilly

Atopic dermatitis (moderate-severe)

CRL

TBD

patisiran (Onpattro)

Alnylam

Transthyretin amyloid cardiomyopathy (ATTR-CM, wild type or hereditary)

CRL

TBD

ravulizumab-cwvz

AstraZeneca

Neuromyelitis optica (Devic’s syndrome)

IV, SC

CRL

TBD

remestemcel-L

Mesoblast

GVHD (acute, steroidrefractory)

CRL

TBD

risperidone (once monthly)

Rovi

Schizophrenia

CRL

TBD

sofpironium

Botanix

Axillary hyperhidrosis (severe)

Topical

CRL

TBD

ustekinumab (biosimilar to Janssen’s Stelara)

Alvotech

PSO; PsA; CD; UC

CRL

TBD

zuranolone

Sage/Biogen

MDD

Oral

CRL

TBD

41 | MAGELLANRX.COM

GLOSSARY 5-FU 5-Fluorouracil

BPH Benign Prostatic Hyperplasia

6MWT 6 Minute Walking Test

BRAF V-raf Murine Sarcoma Viral Oncogene Homolog B1

ABSSSI Acute Bacterial Skin and Skin Structure Infection

BSA Body Surface Area

ACC American College of Cardiology

BsUFA Biosimilar User Fee Act

ACEI Angiotensin-Converting Enzyme Inhibitor

CABP Community Acquired Bacterial Pneumonia

ACR20 American College of Rheumatology 20% Improvement

CAP Community Acquired Pneumonia

ACR50 American College of Rheumatology 50% Improvement

CD Crohn's Disease

ACR70 American College of Rheumatology 70% Improvement

CAR T Chimeric Antigen Receptor T Cell CD3 Cluster of Differentiate 3 CD19 Cluster of Differentiate 19

ADC Antibody-Drug Conjugate

CD20 Cluster of Differentiate 20

ADHD Attention Deficit Hyperactivity Disorder

CD38 Cluster of Differentiate 38

ADL Activities of Daily Living

CD79b Cluster of Differentiate 79b

AED Anti-Epileptic Drug

CDC Centers for Disease Control and Prevention

AHA American Heart Association

CF Cystic Fibrosis

ALK Anaplastic Lymphoma Kinase

CHF Congestive Heart Failure

ALL Acute Lymphoblastic Leukemia

CI Confidence Interval

ALS Amyotrophic Lateral Sclerosis

CKD Chronic Kidney Disease

ALSFRS-R Amyotrophic Lateral Sclerosis Functional Rating Scale-Revised

CLL Chronic Lymphocytic Leukemia

ALT Alanine Transaminase

CMS Centers for Medicare & Medicaid Services

AMD Age-Related Macular Degeneration

CNS Central Nervous System

AML Acute Myeloid Leukemia

COPD Chronic Obstructive Pulmonary Disease

ANCA Antineutrophil Cytoplasmic Antibodies

COVID-19 Coronavirus Disease 2019

ARB Angiotensin II Receptor Blocker

CRC Colorectal Cancer

ARNI Angiotensin Receptor-Neprilysin Inhibitor

CRL Complete Response Letter

ART Antiretroviral Therapy

CRR Complete Response Rate

ARV Antiretroviral

CRS Cytokine Release Syndrome

AS Ankylosing Spondylitis

CSF Colony Stimulating Factor

ASCVD Atherosclerotic Cardiovascular Disease

CTLA-4 Cytotoxic T-Lymphocyte-Associated Protein 4

AST Aspartate Aminotransferase

CV Cardiovascular

BCG Bacillus Calmette-Guérin

CVD Cardiovascular Disease

BCVA Best Corrected Visual Acuity

CYP Cytochrome P-450

BLA Biologics License Application

CYP3A4 Cytochrome P-450 3A4

BMI Body Mass Index BMT Bone Marrow Transplant

DAS28-CRP Disease Activity Score-28 with C Reactive Protein

BP Blood Pressure

DBP Diastolic Blood Pressure

42 | MAGELLANRX.COM

CML Chronic Myeloid Leukemia

GLOSSARY continued DCR Disease Control Rate

HAART Highly Active Antiretroviral Therapy

DEA Drug Enforcement Administration

HAE Hereditary Angioedema

DED Dry Eye Disease

HAM-A Hamilton Anxiety Rating Scale

DLBCL Diffuse Large B Cell Lymphoma

HAM-D Hamilton Depression Rating Scale

DMARD Disease Modifying Antirheumatic Drug

HAMD-17 Hamilton Depression Rating Scale

DMD Duchenne Muscular Dystrophy

HAP Healthcare-Associated Pneumonia

DME Diabetic Macular Edema

Hb Hemoglobin

dMMR DNA Mismatch Repair

HbA1c Hemoglobin A1c

DMT Disease Modifying Therapy

HBV Hepatitis B Virus

DNA Deoxyribonucleic Acid

HCC Hepatocellular Carcinoma

DOR Duration of Response

HCP Healthcare Professional

DPP-4 Dipeptidyl Peptidase 4

HCV Hepatitis C Virus

DR Delayed-Release

HDRS-17 Hamilton Depression Rating Scale

EASI-75 Eczema Area and Severity Index ≥ 75% Reduction

HER Human Epidermal Growth Factor Receptor

ECOG Eastern Cooperative Oncology Group

HF Heart Failure

ED Emergency Department EDSS Expanded Disability Status Scale eGFR estimated Glomerular Filtration Rate EGFR Epidermal Growth Factor Receptor ER Extended-Release ERA Endothelin Receptor Agonist ESA Erythropoietin Stimulating Agent ESRD End-Stage Renal Disease EUA Emergency Use Authorization FDA Food and Drug Administration FH Familial Hypercholesterolemia FLT3 FMS-Like Tyrosine Kinase-3 FMS Feline McDonough Sarcoma GABA-A Gamma-Aminobutyric Acid Receptor Type A G-CSF Granulocyte Colony Stimulating Factor GERD Gastroesophageal Reflux Disease GI Gastrointestinal GIST Gastrointestinal Stromal Tumor GLP-1RA Glucagon-Like Peptide-1 Receptor Agonist GM-CSF Granulocyte-Macrophage Colony Stimulating Factor GVHD Graft Versus Host Disease H Half

43 | MAGELLANRX.COM

HER2 Human Epidermal Growth Factor Receptor 2 HFA Hydrofluoroalkane HFpEF Heart Failure with preserved Ejection Fraction HIT Heparin Induced Thrombocytopenia HIV Human Immunodeficiency Virus HIV-1 Human Immunodeficiency Virus-1 HPV Human Papilloma Virus HR Hazard Ratio HSCT Hematopoietic Stem Cell Transplant HSV Herpes Simplex Virus HTN Hypertension IBS Irritable Bowel Syndrome IBS-C Irritable Bowel Syndrome, Constipation Predominant IDH1 Isocitrate Dehydrogenase 1 IGA Investigator's Global Assessment IgG Immunoglobulin G IgG1kappa Immunoglobulin G1 kappa IL-4 Interleukin-4 IL-12 Interleukin-12 IL-13 Interleukin-13 IL-17 Interleukin-17 IL-23 Interleukin-23 IM Intramuscular IR Immediate-Release

GLOSSARY continued IRB Institutional Review Board

NSAID Non-Steroidal Anti-Inflammatory Drug

ITP Immune Thrombocytopenic Purpura

NSCLC Non-Small Cell Lung Cancer

ITT Intention-To-Treat

NTRK Neurotrophic Tyrosine Receptor Kinase

IV Intravenous

NYHA New York Heart Association

JAK Janus Kinase Inhibitor

ODT Orally Disintegrating Tablet

JIA Juvenile Idiopathic Arthritis

OR Odds Ratio

KIT c-KIT Proto-Oncogene

ORR Overall/Objective Response Rate

LDL-C Low-Density Lipoprotein Cholesterol

OS Overall Survival

LPAD Limited Population Pathway for Antibacterial and Antifungal Drugs

OTC Over-the-Counter

LS Least Square

PAH Pulmonary Arterial Hypertension

LVEF Left Ventricular Ejection Fraction mAb Monoclonal Antibody MACE Major Adverse Cardiovascular Events MADRS Montgomery – Åsberg Depression Rating Scale MAOI Monoamine Oxidase Inhibitor MDD Major Depressive Disorder MDI Metered Dose Inhaler MDR Multi-Drug Resistant MECP2 Methyl-CpG Binding Protein 2 MEK Mitogen-Activated Extracellular Signal-Regulated Kinase MI Myocardial Infarction mITT modified Intention-To-Treat MRI Magnetic Resonance Imaging MRSA Methicillin-Resistant Staphylococcus Aureus MS Multiple Sclerosis MSI-H Microsatellite Instability-High N/A Not Applicable NAFLD Nonalcoholic Fatty Liver Disease NASH Nonalcoholic Steatohepatitis NCCN National Comprehensive Cancer Network NCT National Clinical Trials NDA New Drug Application NHL Non-Hodgkin Lymphoma NIAID National Institute of Allergy and Infectious Diseases NIH National Institutes of Health NRAS Neuroblastoma RAS Proto-Oncogene

44 | MAGELLANRX.COM

PAD Peripheral Arterial Disease PARP Poly (ADP-Ribose) Polymerase PAS Prior Approval Supplement PASI Psoriasis Area and Severity Index PASI 50 Psoriasis Area and Severity Index 50% Reduction PASI 75 Psoriasis Area and Severity Index 75% Reduction PASI 90 Psoriasis Area and Severity Index 90% Reduction PASI 100 Psoriasis Area and Severity Index 100% Reduction PCI Percutaneous Coronary Intervention PCSK9 Proprotein Convertase Subtilisin Kexin 9 PD-1 Programmed Death Protein 1 PD-L1 Programmed Death-Ligand 1 PDUFA Prescription Drug User Fee Application PFS Progression-Free Survival PGA Physician Global Assessment PI3K Phosphatidylinositol-3-Kinase PNH Paroxysmal Nocturnal Hemoglobinuria PsA Psoriatic Arthritis PSO Plaque Psoriasis PTCA Percutaneous Transluminal Coronary Angioplasty PTSD Post-Traumatic Stress Disorder Q Quarter QIDP Qualified Infectious Diseases Product QOL Quality of Life R/R Relapsed or Refractory

GLOSSARY continued R-CHOP Rituximab, Cyclophosphamide, Doxorubicin, Vincristine, Prednisone

TBD To Be Determined

RA Rheumatoid Arthritis

TNBC Triple Negative Breast Cancer

RAS Ras Protein Superfamily RBC Red Blood Cell RCC Renal Cell Carcinoma REMS Risk Evaluation and Mitigation Strategy RMAT Regenerative Medicine Advanced Therapy RNA Ribonucleic Acid ROS1 ROS Proto-Oncogene 1 RPD Rare Pediatric Disease RRR Relative Risk Reduction RSV Respiratory Syncytial Virus RTOR Real-Time Oncology Review RVO Retinal Vein Occlusion SARS-CoV-2 Severe Acute Respiratory SyndromeAssociated Coronavirus-2 sBLA supplemental Biologics License Application SBP Systolic Blood Pressure SC Subcutaneous SCCHN Squamous Cell Cancer of the Head and Neck SCD Sickle Cell Disease SCLC Small Cell Lung Cancer SCT Stem Cell Transplant SGLT2 Sodium-Glucose Co-Transporter 2 SL Sublingual SLE Systemic Lupus Erythematosus SLL Small Lymphocytic Lymphoma sNDA supplemental New Drug Application SNRI Serotonin and Norepinephrine Reuptake Inhibitor SOC Standard of Care SOD-1 Superoxide Dismutase - Type 1 sPGA static Physician Global Assessment SR Sustained-Release SSRI Selective Serotonin Reuptake Inhibitor SSSI Skin and Skin Structure Infection T1DM Type 1 Diabetes Mellitus T2DM Type 2 Diabetes Mellitus

45 | MAGELLANRX.COM

TEAE Treatment-Emergent Adverse Event TNF Tumor Necrosis Factor TNFα Tumor Necrosis Factor-alpha UA Unstable Angina UC Ulcerative Colitis US United States UTI Urinary Tract Infection VAS Visual Analog Scale VEGF Vascular Endothelial Growth Factor VTE Venous Thromboembolism WBC White Blood Cell WHO World Health Organization XR Extended-Release

MRx PIPELINE A VIEW INTO UPCOMING SPECIALTY & TRADITIONAL DRUGS

JANUARY 2022