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Guest editorial

New one-stop guideline for cardiovascular health in Canada

Anew one-stop guideline takes a 360-degree approach to managing heart disease in Canadian patients, with 83 recommendations in one easy-to-use reference. The guideline is published in CMAJ (Canadian Medical Association Journal).

“Clinicians are rightly concerned that there are too many guidelines with too many individual recommendations to be practical and useful for daily use, particularly in primary care. Typical patients with multiple illnesses require the access to many guidelines at the same time, and some recommendations are not harmonized and often seem contradictory,” says Dr. Peter Liu, chief scientific officer at the University of Ottawa Heart Institute, and a senior author of the latest C-CHANGE guideline. “We hope this fourth update to the very popular C-CHANGE guideline will further meet the needs of health professionals and patients, to prevent and treat cardiovascular conditions and associated brain health with a simple harmonized approach.”

An update to a 2018 publication, the Canadian Cardiovascular Harmonized National Guideline Endeavour (C-CHANGE) resource includes 48 new or revised recommendations out of the 83, from 11 cardiovascular-focused guideline groups across the country.

Aimed at primary care and other health care providers, the C-CHANGE guideline contains actionable recommendations for Canadian adults with or at risk of cardiovascular disease, including • people with obesity, diabetes or hypertension; • people with dyslipidemia, atherosclerotic vascular disease or heart failure; and • people with atrial fibrillation, stroke or dementia.

It also includes health behaviour recommendations for all Canadians to address risk factors for these conditions, such as dietary, smoking and physical activity considerations.

“C-CHANGE is all about singing from the same song sheet,” says Dr. Sheldon Tobe, co-chair of C-CHANGE and nephrologist at Sunnybrook Health Sciences Centre. “Our goal is to help health care providers understand the evidence for best practices, and if they can follow the guidelines, the health of the Canadian population could substantially improve.”

What’s different from before?

More than 50 per cent of the guideline contains new or revised recommendations from the previous 2018 version. This guideline is also more comprehensive and holistic in caring for patients with multimorbidity.

Partnership has expanded to include Health Canada’s Dietary Guideline, the Canadian Consensus Conference on Diagnosis and Treatment of Dementia, and the Canadian Cardiovascular Society/ Canadian Heart Rhythm Society guide-

Continued from page 4 Medicare crisis

• Establish a central triage system for specialists so that those in high need in a region or province are directed to the first available diagnostic spot or specialist.

Canadians should also demand the federal government take every step it can to improve public medicare immediately.

Emergency federal funding is needed but must come with a fair request that provinces be transparent with their budgets and outline the difference any new investments from the federal government will make.

Why? Premier Ford in Ontario has sat on billions of dollars of federal funding for the COVID-19 response, for example. The citizens of Ontario deserve to know how every single new federal dollar will be invested to improve public medicare now.

The federal government should also flex all its other levers of constitutional powers to support public medicare at this time. This includes further investments to support fast-track accreditation of the thousands of immigrant health care workers across Canada who want to work but are not permitted to do so.

The federal government should also create a Medicare Ombudsman to hear and document the concerns of patients so we can have a clear sense of both distinct and common issues across the country.

There is a window of opportunity in this moment of crisis to radically improve public medicare. But this crisis also presents an unprecedented opening for those who seeking to profit from the erosion of public services and our collective faith in the public system.

Canadians need to stand up for public medicare now, for they will sorely miss it when it’s gone. ■ H

Colleen M. Flood is the University of Ottawa Research Chair in Health Law & Policy and Director of the University of Ottawa Centre for Health Law, Policy and Ethics. line for the management of atrial fibrillation. It also includes a subsection on depression given its frequent co-existence and impact on cardiovascular disease.

“In the past four years, many of the national guideline organizations have launched new, evidence-based recommendations – from changes in medication management to new thresholds for lipid levels in secondary prevention,” says Dr. Rahul Jain, co-chair of C-CHANGE and family physician at Sunnybrook Health Sciences Centre. “We hope this resource helps primary care clinicians stay up to date with many constantly evolving cardiovascular guidelines, so their patients can get the best care possible.”

“Canadian Cardiovascular Harmonized National Guideline Endeavour (C-CHANGE) guideline for the prevention and management of cardiovascular disease in primary care: 2022 update” was published November 7, 2022. ■ H

Emergency Departments aren’t the cure for our mental health crisis

With rising mental health care needs and Emergency Departments stretched past their limits, Canada must act now to cover mental health care, both before and after people are in crisis. So says the Canadian Mental Health Association (CMHA) with a network of Canadian organizations as they launch Act for Mental Health, an advocacy campaign calling for the creation of the promised Canada Mental Health Transfer.

Mental illnesses and substance use disorders will affect one in three Canadians in their lifetime, and research shows the pandemic made things worse. Of those millions of people, one in three can’t get the care they need. Some will wind up in Emergency Departments.

“When someone is in a mental health crisis, all roads lead to a hospital,” says Margaret Eaton, CMHA National CEO. “There is often nowhere else to turn, but Emergency Departments aren’t the cure for our mental health crisis.” Eaton goes on to say: “We’re also failing people once a crisis passes. Often, they’re discharged without the care they need because it either does not exist, or it isn’t covered.”

Under the Canada Health Act, mental health care is only covered by public health insurance when it is provided by physicians and/or in hospitals, Millions of Canadians don’t have a family doctor and can wait months, or more, to see a psychiatrist. Family doctors face challenges in caring for patients with mental health concerns, and publicly funded referral options are scarce.

As a conservative estimate, Canadians pay over $1 billion every year on private psychological services alone. While some free mental health and substance use health services exist, persistent underfunding to community-based agencies means wait lists are long and services are limited. When we can’t afford to pay, often we don’t get the care we need, which can lead to crisis and to hospital.

Canadians are encouraged to Act for Mental Health by visiting www. actformentalhealth.ca and getting involved. ■ H

Ontario pharmacists association launches new digital health tool to support minor ailments program

The Ontario Pharmacists Association (OPA) has partnered with MAPflow, a powerful new digital health tool to support pharmacists when they assess and prescribe for minor ailments in the province starting January 1, 2023.

Minor ailments are health conditions that can be managed with minimal treatment and/or self-care strategies. They are often short-term conditions where lab results aren’t typically necessary, and there’s a low risk of treatment masking underlying conditions.

Pharmacists manage highly confidential patient data and must meet

THE PANDEMIC FURTHER HIGHLIGHTED THE NEED FOR MULTIFACETED, SUSTAINABLE PRIMARY AND COMMUNITY-BASED HEALTHCARE SOLUTIONS.

“THE OVERALL RATES OF MYOCARDITIS PER 100 000 DOSES WERE STILL VERY LOW FOR BOTH VACCINE PRODUCTS,”

strict privacy, security, and governance requirements when implementing minor ailments services next year. As they transition to the expanded role, MAPflow’s advanced software platform streamlines documentation, offering pharmacists a simplified workflow and seamless experience.

OPA’s investment in this web-based clinical decision-making and implementation support platform provides pharmacists with a comprehensive suite of custom-built applications designed for Ontario’s practice environment.

“As the unified voice representing thousands of Ontario pharmacy

Study finds that risk of myocarditis after SARSCoV-2 vaccination is increased but very low

Alarge study found that myocarditis after SARSCoV-2 vaccination was rare but higher in younger males, especially after the second mRNA-1273 (Moderna) vaccine, suggesting that vaccine type, age and sex should be considered when vaccinating. The study is published in CMAJ (Canadian Medical Association Journal).

“In this study, we found higher observed rates of myocarditis after receipt of mRNA vaccines than expected, but absolute rates were low,” writes Dr. Naveed Janjua, School of Population and Public Health, University of British Columbia and the British Columbia Centre for Disease Control, Vancouver, BC, with coauthors.

Researchers analyzed population health data from the BC COVID-19 Cohort, which included more than 10.2 million doses of mRNA vaccines administered to people aged 12 years and older from Dec. 15, 2020, to Mar. 10, 2022. Almost seven million were BNT162b2 (Pfizer-BioNTech) doses and 3.2 million were mRNA-1273 (Moderna) doses. The researchers identified people who were admitted to hospital or visited an emergency department because of myocarditis within seven and 21 days of receiving the vaccine.

On average, the rate of myocarditis 21 days after vaccination was 1.37 per 100 000 people compared with an expected rate of 0.39 per 100 000 people not vaccinated. The highest rates of myocarditis were in males (rate: 2.15/100 000), among those aged 18–29 (rate: 2.97/100 00), after the second dose (rate: 2.27/100 000 doses) and in people vaccinated with mRNA-1273 (Moderna) (rate: 1.75/100 000). Among males aged 18–29 who received the mRNA1273 (Moderna) vaccine, the rate was 22.9/100 000 doses. After the third dose, rates of myocarditis were lower, including among people aged 18-29.

“The overall rates of myocarditis per 100 000 doses were still very low for both vaccine products,” write the authors. However, they state that their findings “… support the preferential use of the BNT162b2 (Pfizer-BioNTech) vaccine over the mRNA-1273 (Moderna) vaccine for people aged 1829 years.”

A US analysis estimated that 11 000 COVID-19 cases, 560 hospital admissions, 138 ICU admissions and 6 deaths from COVID-19 could be prevented per million second doses of mRNA SARS-CoV-2 vaccine administered to males aged 12–29 years, compared with 39–47 expected cases of myocarditis after SARS-CoV-2 vaccination.

“[T]he benefits of vaccination against SARS-CoV-2 in reducing the severity of COVID-19, hospital admission and deaths far outweigh the risk of developing myocarditis.… Thus, continued vaccination of this group, along with monitoring of adverse events, including myocarditis, should remain the preferred strategy,” the authors conclude.

“Observed versus expected rates of myocarditis after SARS-CoV-2 vaccination: a population-based cohort study” was published Nov. 21, 2022. ■ H professionals, OPA works with government in enabling pharmacists to create additional capacity in healthcare,” notes Jennifer Belcher, RPh., a practicing pharmacist and VP of Strategic Initiatives and Member Relations at OPA. “We’re committed to helping pharmacists increase agility and drive innovation for the future. OPA has invested in MAPflow to successfully prepare pharmacists to make confident, evidence-based decisions while assessing patients for minor ailments.”

MAPflow is industry-specific software designed by a team of leaders in Ontario pharmacy education, led by community pharmacist and academic Nardine Nakhla, PharmD.

Through Dr. Nakhla’s research and significant expertise in minor ailments, she recognizes the importance of reliable, resilient, interconnected health systems. The pandemic further highlighted the need for multifaceted, sustainable primary and community-based healthcare solutions. “MAPflow facilitates minor ailment prescribing services for pharmacists and integrates this new element into their practice while optimizing patient outcomes,” notes Dr. Nakhla. “This exciting tool captures unique analytics, promotes shared clinical decision-making, and aligns with provincial legislation. Most importantly, it enables pharmacists to provide patients with customized care.” The approach aligns with the Ministry of Health’s objective to provide more pathways for patients to access care in the community and reduce the need for emergency or urgent care visits.

Partnering to launch this tool demonstrates OPA’s visionary leadership and proud role as a driving force for modernization and digital health transformation. These strategic investments represent a key feature of the Association’s long-term vision toward expanding the scope of practice for pharmacy professionals.

To learn more about MAPflow and purchase a subscription for this specialized program, visit opatoday.com. ■ H

NEWS Monkeypox vaccine modelling study provides road map for vaccination

Amodelling study to explore optimal allocation of vaccines against monkeypox virus (MPXV) provides a road map for public health to maximize the impact of a limited supply of vaccines. The article, published in CMAJ (Canadian Medical Association Journal), confirms that prioritizing vaccines to larger networks with more initial infections and greater potential for spread is best.

“We hope that these insights can be applied by policy-makers across diverse and dynamic epidemic contexts across Canada and beyond to maximize infections averted early in an epidemic with limited vaccine supply,” says Dr. Sharmistha Mishra, MAP Centre for Urban Health Solutions, Unity Health Toronto.

As of November 4, 2022, there were 1444 cases of MPXV in Canada, disproportionately among gay, bisexual and other men who have sex with men (GBMSM). A very limited supply of smallpox vaccines is available and is being prioritized to populations experiencing disproportionate risks.

Researchers modelled two hypothetical cities as interconnected networks with a combined GBMSM community size of 100 000. The team then varied the characteristics of the two cities across a range of plausible settings and simulated roll-out of 5000 vaccine doses shortly after the first detected case of MPXV.

They found that the strongest factors for optimal vaccine allocation between the cities were the relative reproduction number (epidemic potential) in each city, share of initial cases, and city (or network) size. If a larger city had greater epidemic potential and most of the initial cases, it was best to allocate the majority of vaccines to that city. The team varied the reproduction number with a single parameter, but they highlight how many factors could influence local epidemic potential, including the density and characteristics of the sexual network, access to prevention and care, and the underlying social and structural contexts that shape both sexual networks and access.

“Under our modelling assumptions, we found that vaccines could generally avert more infections when prioritized to a larger network, a network with more initial infections and a network with greater epidemic potential,” writes Jesse Knight, lead author and PhD candidate at the University of Toronto and MAP Centre for Urban Health Solutions, Unity Health Toronto. “Our findings further highlight the importance of global vaccine equity in responding to outbreaks, and also in preventing them in the first place,” he says.

The study emphasizes the interconnectedness of regions and that a population-level perspective is necessary.

“Strategic prioritization of a limited vaccine supply by network-level risk factors can maximize infections averted over short time horizons in the context of an emerging epidemic, such as the current global MPXV outbreak,” conclude the authors.

“Maximizing the impact of limited vaccine supply under different early epidemic conditions: a 2-city modelling analysis of monkeypox virus transmission among men who have sex with men” is published November 28, 2022 ■ H

Zapping brain cancer with long needles opens door to new treatments

University of Saskatchewan (USask) researchers have developed a new method of killing brain cancer cells while preserving the delicate tissue around it. The technique also has a remarkable side-benefit: making chemotherapy treatment of brain cancer suddenly possible.

The technique involves placing long needles through the skull and sending pulses of electrical current into a glioblastoma tumour – the pernicious variety of brain cancer that caused Tragically Hip frontman Gord Downie’s death.

“A safer and more effective cancer treatment may be clinically possible,” said Dr. Mike Moser (MD), USask College of Medicine general surgery researcher and co-author of a study published recently in the Journal of Biomechanical Engineering.

“Patients with brain tumours may now have another option for local treatment that does not involve opening the skull, and does not involve heat or radiation.”

The USask-led research team created 3D models of cells to test which treatment protocols of electrical current – called irreversible electroporation (IRE or NanoKnife) and high-frequency irreversible electroporation (H-FIRE) – can destroy glioblastoma cells while minimizing the risk to surrounding tissues and blood vessels.

Glioblastoma, the most aggressive and deadly form of brain cancer, affects one in 25,000 Canadians, and only six per cent of those with the cancer currently survive longer than five years after diagnosis.

The technique relies on how glioblastoma cells respond to the electrical current. The researchers discovered tumour cells can be killed with a smaller electrical field than would kill surrounding healthy tissues.

They also discovered that this technique temporarily disrupts the blood-brain-barrier – the semi-permeable membrane that allows only tiny molecules to pass from the blood into the brain.

“The blood-brain barrier prevents many treatment drugs from getting to the tumour,” said USask biomedical engineering researcher Dr. Chris Zhang (PhD), co-author on the study. “We’ve shown that our technique can also help to open this barrier, so the brain is better able to receive other treatments – like chemotherapy or drugs that help increase the immune response – and help the patient fight the tumour in a systematic manner.”

The team also involved USask doctoral student Lujia Ding, and post-doctoral fellow Dr. Zheng Feng (PhD), as well as researchers from China’s Fudan University and Shanghai University. The project is part of an extended collaboration with Dr. Bing Zhang (PhD), a former USask doctoral student of Moser and Zhang.

The research was funded by CREATE and Discovery Grants from Canada’s Natural Sciences and Engineering Research Council, a grant from the Royal University Hospital Foundation, and a grant from National Natural Science Foundation of China to Dr. Bing Zhang and his team.

The next step in the research is to develop a combined method of tumour removal and immunotherapy using their H-FIRE technique. ■ H

Collaborating to improve data sharing in Canada

By Abigail Carter-Langford

The COVID-19 pandemic and the increased use of virtual care have intensified the calls for timely and accurate data sharing in Canada. We can answer the calls by taking a collaborative pan-Canadian approach to secure data sharing in a digital environment that empowers patients and clinicians while protecting patient information.

Canada Health Infoway (Infoway) recently published a white paper called A Path Forward for Data Sharing In Canada that champions this approach, and makes it clear that privacy is NOT a barrier to data sharing. The white paper was developed through a literature review, key reports published during the pandemic, and consultations with stakeholders including privacy commissioners and privacy leaders, clinicians, patients and health technology providers. Many of these stakeholders are living and breathing the challenges of data sharing every day, so it’s vital that their voices be heard.

The observations and recommendations in the paper are based on these underlying principles: enables better health care for patients and improves the overall Canadian health care system; sharing among their providers; creased control over their health data; and dictions is desirable because it benefits all Canadians.

The rapid adoption of virtual care during the early months of the pandemic put a stark focus on the privacy controls and processes around the sharing of health data. As one privacy leader who participated in our consultations put it, “all the tiny gaps in the systems got highlighted.” From to clearly articulate the barriers and challenges, identify opportunities, and propose solutions.

The barriers and challenges fall into these categories: guidance and education on permissible uses and disclosures of data is unclear; lative roles of the parties, which is a key enabler to setting efficient rules for collections, uses and disclosures; participants in a data system share the decision-making around data) is not well-understood, making the obligations of each party unclear.

This impedes timely implementation of these kinds of arrangements and sharing agreements; risks of protecting personal health between data custodians and service providers and may create a discrepancy between assumption and ability to mitigate risk; provided to custodians and this gap can result in fear of penalties for unauthorized disclosure/sharing; sharing agreements and resources to support data sharing; and can and should share in protecting and enabling data sharing is unclear. The white paper goes into much greater detail about each category, so I’ll focus now on the opportunities we’ve identified and the solutions we propose.

There is a need for clear frameworks and standards for health technology providers and custodians that provide greater clarity about how to abide by privacy and security best practices will support practical and enforceable measures to enable a common “language for everyone to speak” and a common set of rules to follow, and will help establish trust.

We need to move from considering only custodianship, and toward embracing a model of information stewardship. This shift in perspective will give clinicians access to the data they need to provide care, while retaining curity of the data, and it could enable patients to have more meaningful ac

We need to take opportunities to modernize our data governance legislation to consistently put patients at the centre. We should also continue to embed data sharing within privacy legislation including considering where health technology providers may play a key role in ensuring data protection.

There are also benefits to be gained from data literacy education, including privacy education, for patients, as well as privacy training and education for health technology providers and custodians. This raises awareness of the cy over their data, and ensure that all enable important data sharing.

As I mentioned at the outset, the path forward for data sharing pan-Canadian approach. Infoway and our partners and stakeholders have already made strides in some areas, such as national procurement of virtual care solutions, a digital health literacy program for Canadians, and the creation of a pan-Canadian interoper There is much more work to be done, so we hope this discussion leads to continued and growing collaboration and, most importantly, concrete action. H

Antimicrobial resistance:

A year in review

By Jessica Blavignac

Despite extensive scientific research and policy developments, urgent coordinated action is needed to tackle the growing threat of antimicrobial resistance (AMR), often referred to as a the next (silent) pandemic

UNDERSTANDING AMR

AMR occurs when antimicrobials are no longer effective against the microorganisms they were designed for, leaving no treatment options to fight infections. AMR occurs naturally as microorganisms like bacteria, viruses, fungi, and parasites change or adapt over time, either by modifying the target of the antimicrobial, or by developing and exchanging resistance. The overuse and misuse of antibiotics in humans, animals and plants is speeding up this process

HOW DOES AMR SPREAD?

Some of the factors contributing to the spread of AMR globally include: • The use of antibiotics in agriculture, veterinary medicine and food production • Poor infection prevention and control practices • Non-optimal use of diagnostic tools for rapid and reliable detection of pathogens and resistance • Access barriers for efficacious vaccines • Lack of antibiotics to treat infections caused by multidrug resistant bacteria • Weakness or absence of surveillance programs to track localized cases of

AMR • Absence of a global, uniform and coordinated response between all countries • Globalization as the population, animals and food products travel more, spreading resistance more quickly and easily between countries and continents

But scientific experts highlight the main reason for the spread of AMR is overuse and misuse of antibiotics.

STUDYING AMR’S IMPACT

It is estimated that more than 5,400 Canadians die every year from infections caused by bacteria that have become resistant to antibiotics. Worldwide, AMR is linked to close to five million annual deaths, more than HIV/AIDS, malaria, or breast cancer. According to a quantitative model developed for the Council of Canadian Academies using existing data, a panel of experts found that in Canada, 26 per cent of infections are resistant to the drugs generally used to treat them. The same report also states that by 2050, resistance rates are likely to rise to 40 per cent which could result in the loss of 15 Canadian lives daily and $396 billion in gross domestic product (GPD).

AMR has been recognized as a global emergency by the World Health Organization (WHO), Centers for Disease Control, and was discussed at the 17th G20 Heads of State and Government Summit in Bali, Indonesia. International policy bodies and governments have added AMR near the top of their political agenda and have been calling for more research and action plans.

MAKING PROJECTIONS FOR 2023

The cost of AMR to national economies and their health systems is significant as it affects the productivity of patients and their caregivers due to prolonged hospital stays and the need for more expensive and intensive care. Without effective tools for prevention, adequate treatment of drug-resistant infections, and access to existing and new quality-assured antimicrobials, the number of people failing treatment or dying from infections will increase. A major part in the strategic reduction of AMR lies with diagnostic devices that can inform and support clinical decision-making. This helps ensure that the right antibiotic treatment (dosage and duration) is given to the right patient for the right condition. In particular, new syndromic diagnostic technologies allow microbiology labs to provide this information faster and more accurately than ever before.

The pandemic has shown Canadians the importance of these and several modern, fast, innovative devices that have been deployed by the federal government. This allowed people to get tested close to home, in their area. Diagnostic tests can play a major role for the optimal diagnosis of an individual, for the optimal and cost-effective functioning of health systems and for the benefit of the general public.

In fact, already in the early 2000s, research developments were underway to transform in vitro diagnostics from central laboratory to ‘near patient’ or ‘at bedside’. We are at the cusp of seeing such testing available in Canada, extending beyond clinical biochemistry (e.g. glucose monitoring for diabetes mellitus) to other pathology disciplines, including microbiology and hematology.

AMR is an ongoing and growing problem affecting Canada in several ways. While it is important to look at what we already know and what has been done thus far, we can now look forward to how diagnostic stewardship and near-patient testing will help in the fight against AMR. ■ H

Passion for health:

How Samsung Bioepis is innovating access to healthcare

By Samsung Bioepis

Samsung has become a global leader across various industries over the last 85 years, propelled by the drive for unmatched quality, supply resilience and innovation. Having that drive rooted in Samsung DNA, Samsung Bioepis is expanding its presence in the biopharmaceutical sector with an aim to improve access to healthcare.

Established in 2012, Samsung Bioepis is a biopharmaceutical company dedicated to unlocking the potential of biosimilars, and is committed to improving the accessibility of treatments for patients around the world. Our mission is reflected in our name – it is taken from the Greek words ‘bio’ meaning life, and ‘episteme’ meaning science.

A decade ago, although biosimilars were not known to many, we decided to develop biosimilars as we believed biosimilars could bring value to patients, healthcare professionals, payers and many other stakeholders within the wider healthcare system by increasing access to biologic medicines.

Biosimilars are biologic medicines that are highly similar to an already approved biologic drug, known as the reference biologic drug. There are no expected clinically meaningful differences in efficacy and safety between a biosimilar and the reference product authorized for sale, according to Health Canada.i

Within just a decade, Samsung Bioepis has become one of the major players in the global biopharmaceuticals sector, achieving this by expansively developing our biosimilars portfolio in a range of therapeutic areas including immunology, oncology, ophthalmology, hematology and endocrinology.

We use a data-driven approach and rigorous quality control in its biosimilar development processes – from the preclinical stage to large-scale manufacturing – to produce cost-effective medication in a shorter period of time, or what we call it as ‘process innovation’.

By focusing on process innovation and establishing strong partnerships, Samsung Bioepis has six biosimilars that are authorized for sale and are available around the world.

Our innovative research and development platforms, combined with manufacturing and partnerships have helped us to establish a global footprint, so we can provide biosimilars to those who need them most.

Through global commercialization partnerships, we have extended our sales and marketing network to broaden the availability of our biosimilars to patients around the world.

In Canada, we have commercialization partnership with Organon, who have been working tirelessly with local physicians, pharmacists, and regulators to bringing quality medicine to Canadian patients. For our ophthalmology biosimilar portfolio in Canada, we have commercialization partnership with Biogen.

Having similar safety and efficacy as reference biologic drugs and meeting the same rigorous regulatory standards, biosimilars have been authorized for sale in Canada since 2009.ii

Increasing the use of biosimilars authorized for sale by Health Canada would not only allow increased access and choice, but also bring medicines at more affordable costs to the Canadian healthcare system.iii iv Savings from biosimilars can support creating a more sustainable, cost-effective way to treat patients.v

Samsung Bioepis emphasizes the importance of making sure its products are delivered on time, so that patients can receive treatments at the right time. Supply chain and product continuity are the most important aspects of its mission, and it has made a promise to its patients that it will deliver medicines.

By having geographically diversified manufacturing and storage sites across three continents – North America, Europe and Asia, this “near-market” strategy gives us an edge that allows us to remain vigilant and respond quickly to market dynamics.

At the core of our business and vision are the patients around world without viable treatment options. This is why we are further committed to fulfilling our social responsibility and becoming a sustainable company, which is also a part of Samsung Philosophy - devoting one’s talent and technology to creating products and services that contribute to a better global society.

As a biopharmaceutical company, we will continuously build our profile and presence in Canada and elsewhere around the world, while educating prescribers, patients and other stakeholders on the benefits that biosimilars can provide to the healthcare system.

Samsung Bioepis’s work remains far from finished. H

i Health Canada, Biosimilar biologic drugs in Canada: Fact Sheet, https://www.canada.ca/en/health-canada/services/drugs-health-products/biologics-radiopharmaceuticalsgenetic-therapies/applications-submissions/guidance-documents/fact-sheet-biosimilars.html ii Patented Medicine Prices Review Board, Biologics in Canada. Part 1: Market Trends, 2018 https://www.canada.ca/en/patented-medicine-prices-review/services/reportsstudies/biologics-part1-market-trends.html iii Canadian Agency for Drugs and Technologies in Health, Biosimilar Drugs https://www.cadth.ca/sites/default/files/pdf/biosimilar_drugs_patient_en.pdf iv Biosimilars Canada, The Benefits of Biosimilar Medicines https://biosimilarscanada.ca/wp-content/uploads/2020/12/Module5_final_EN.pdf v Patented Medicine Prices Review Board, Biologics in Canada. Part 2: Biosimilar Savings, 2018 https://www.canada.ca/content/dam/pmprb-cepmb/documents/reports-andstudies/chartbooks/biologics-part2-biosimilar-savings2018.pdf

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