45 minute read
Generics
4Generics
Whether treating simple ailments or chronic degenerative diseases, generics companies are a significant contributor to Mexico’s healthcare industry and economy, while providing an accessible solution for patients paying out of pocket.
In 2020, the generics industry experienced favorable changes regarding production. COFEPRIS eliminated criteria that limited generics manufacturing once the corresponding patent expired. Meanwhile, the new Industrial Innovation Protection Law derived from USMCA sought to speed up the entry of generics to the market by helping producers to prepare for when the patents expire. However, changes to the centralized medicine purchasing scheme and the federal medicine supply coming from UNOPS present a challenge for this industry.
Overall, generics sales experienced 19.1 percent growth last year, according to ANADIM’s figures. Looking ahead, industry players are focusing on biosimilar production, opening dialogue with Mexican authorities, expansion and an overall strengthening of the industry in terms of quality and production capacity. Large multinational players are even taking a positive look at Mexico’s chemical pharmaceutical industry to exploit its manufacturing capabilities for API production. This chapter explores an important industry for the country’s micro and macro economy, with hopes for a thriving 2021.
4Generics
67 Analysis
Mexico’s API Manufacturing Potential Boosted by COVID-19
68 View From the Top
Arturo Morales | President of AMELAF
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Cecilia Bravo | President of ANAFAM
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Jaime López de Silanes | Executive Director of CFM
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Juan José Aguirre | Commercial Director of Grupo Bruluart
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Rodrigo Hernández | Director General of Quimpharma
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Efrén Ocampo | President of Grupo Neolpharma
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Benjamín Vega | Commercial Director of Allen Laboratorios
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Rafael Quintanilla | Pharma and Biologics Director of Laboratorios Silanes
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Américo García | Director General of Mexico and Latin America at Apotex
78 View From the Top
MS Nagendra | Director General of Zydus Pharmaceuticals
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Vincenzo D’Elia | General Manager of Laboratorios Alfasigma
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Esteban Abad | Vice President and Head of Upper Latin America at Glenmark
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Lourdes López | Executive Director of ANADIM
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Ignacio Merino | Director General of Farmacia París
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Gabriel Zavala | Commercial Executive Director of Farmacias del Ahorro
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Santiago González | Operations Director Mexico of Farmacias YZA
Read the complete article COVID-19 demonstrated the world’s dependence on certain markets. In the healthcare industry, this was clearly evident in the logistics and supply chain disruptions related to API production, which mainly happens in Asia, specifically in India and China. The resulting calls for nearshoring production put Mexico in a good position to capitalize on its strengths.
WHO describes Active Pharmaceutical Ingredients (API) as “any substance used in a finished pharmaceutical product, intended to furnish pharmacological activity, to otherwise have direct effect in the diagnosis, cure, mitigation, treatment or prevention of disease or to have direct effect in restoring, correcting or modifying physiological functions in human beings.”
According to MDTV Alliance, depending on the complexity of the molecule required, synthesis of APIs might require multistep complex chemistry using a range of processing technologies. API manufacturers are highly specialized and globally, Teva, with headquarters in Israel, and Dr.Reddy’s, located in India, are two of the largest API manufacturers.
Manufacturing APIs involves a regulated process that requires strict safety and quality standards. While these are determined by each country, the final API product is inspected and licensed by the regulatory entity of each country where it arrives; for example, the FDA in the US and COFEPRIS in Mexico. However, MDTV Alliance warns that “regular inspection outside the country of use can prove difficult with counterfeiting and contamination being high on the list of various agencies’ concerns.”
During the COVID-19 pandemic, API distribution was disrupted when India and China limited logistics operations to secure internal supply. This caused global concerns and production delays but it also raised a question: Could this be an opportunity for Mexico?
In an interview with MBN, President of the Mexican Pharmaceutical Council (CFM) Jaime López de Silanes explained that China and India represent around 80 percent of the global API market. “Mexico needs strategic mechanisms between the government and the pharmaceutical industry to promote national API production and reduce this dependence,” said Silanes. This is an opportunity for the country, especially now with USMCA’s enforcement. “Even the US is actively promoting this route, which makes this an ideal time for Mexico, the US and Canada to promote medium and long-term commitments between companies and governments to create certainty for investments.”
Esteban Abad, Vice President and Head of Upper Latin America at Glenmark, told MBN that Mexico has potential as an API manufacturer but that it might not be quite ready for it. “It has been said that Mexico could become an API producer but it is not that simple. While we might have manufacturing capabilities, there needs to be a specific demand to fully develop them as the infrastructure required for a single API is not cheap.” Abad added that for the goal to become a reality, Mexico would need global demand to ensure profitability.
Arturo Morales
President of AMELAF
Pushing for Cooperation Between the Public, Private Sectors
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More about this person Q: How is AMELAF helping to shape and grow the Mexican pharmaceutical industry?
A: AMELAF represents 44 national laboratories with 100 percent Mexican investment, having 63 plants that comply with COFEPRIS’ standards and working to the highest international pharmaceutical standards. We encourage COFEPRIS to visit those plants to ensure the quality work of our laboratories. This sector is a direct employer of at least 90,000 people and generates 400,000 indirect jobs in Mexico.
AMELAF’s focus is to boost competition among national laboratories. We are in charge of distributing almost threefourths of the medicine that the public sector requires, charging only a third of what these medicines really cost. We are interested in defending and representing the national pharmaceutical industry before the government, which is our main client and regulator. AMELAF builds communication bridges between companies and the government. We promote dialogue and participation so both parties can fulfil their interests while generating a positive impact on society. At the end on the day, companies and the government have the same interest to contribute to the Mexican healthcare sector and to promote well-being.
Q: How is AMELAF connecting to public institutions and supporting its members during this complex period?
A: AMELAF’s main focus is on the centralized purchasing system, which was recently implemented to address the areas of opportunity in the old purchasing system. The main flaw I saw with the old system was the distribution of the budget rather than of the medicine itself. The new system combats the misuse of resources, which is a very assertive measure and will benefit the healthcare sector. However, the way it was implemented was abrupt and generated issues that could have been avoided with proper timing. It is worth mentioning that there was no such thing as a monopolistic sale. Seventy laboratories sold to three distributors, which generated the receipt for the government. That ended up looking like a monopolistic practice. Laboratories had the option of working directly with the government but it was less complicated to work through a distributor.
What the pharmaceutical industry wants is clarity regarding demand and work hours. Mexico and its current national contractors have the capacity to fully supply the government’s requirements. Holding an open international tender was a step that could have been avoided because, aside from all the legal procedures, the purchase could be dangerous if not done under the same regulatory measures that COFEPRIS establishes, not to mention that it is unfair to national companies that do follow the national acquisition law.
The government backed up its decision by saying WHO validated those medicines, which is not entirely true. WHO allows the entrance of those medicines to underdeveloped countries or in cases of a crisis or emergency, which is not the case for Mexico. We are not facing a shortage; the Mexican pharmaceutical industry has the capacity to cover those gaps but has no certainty from the government. We depend on what the public sector requires and if there is no clarity, the result is that medications cannot be manufactured on time, leading to shortages.
Cecilia Bravo
President of ANAFAM
Inconsistent Medication Purchases Hurting National Sector
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More about this person Q: What steps has ANAFAM taken to guarantee manufacturing and supply during the pandemic?
A: Our sector did not halt activities. However, in the area of raw materials, we did have a few issues in a number of cases. Some countries restricted the export of certain supplies. This was a problem when the supplier was bound to a specific SKU here in Mexico. In these cases, we asked the sanitary authority to authorize imports from a different supplier. COFEPRIS provided some support on the issue but only to a certain extent. There were about 20 cases where imported supplies were at risk.
Q: Do you expect greater flexibility in adapting imports in the future?
A: We have a problem with the current regulatory situation, which is very complex and does not benefit the industry. During the COVID-19 crisis, the authorities have actually been introducing new regulations that place an even greater burden on companies in Mexico. These regulations do not have to do with COVID-19. Companies that have been waiting for procedures to be completed now have to meet new requirements that set back their plans. Instead of simplifying, the government is making things more and more complicated.
Q: Where does medication development in Mexico stand at the moment?
A: We have some labs that have their raw material manufacturing here. One of our members specifically manufactures only raw materials. For Mexican manufacturers, it is better to focus on a specialized medical product that can be marketed in a smaller volume market at a higher price. This can provide a return without a major investment up front. If we wanted to compete with China or India in the large volume markets, we would need a great deal of capital.
Q: What impact is the government’s approach to buying medication having on the sector?
A: Under previous FTA conditions, the Mexican government would set more requirements for public sector purchasing that would give preference to products that were more strongly integrated in the national productive chain. This was lost with the new free trade negotiations.
We support getting medications from elsewhere if there is no provider in the country. However, with many imports, this is not the case. I believe the government could still handle a not-socostly mechanism where, in the case of two available providers, the government gives preference to the one with the larger national presence. I do not see this happening, however.
Q: What actions are you taking to improve this situation?
A: We are filing an amparo against a disposition proposed by the government that lowers the import requirements for many products, particularly in the oncological area. The government is opting for direct purchases without any bidding process. Formerly, things happened according to structured bidding processes. Manufacturers would be informed of the demand from the public sector, which would allow them to plan their production.
Jaime López de Silanes
Executive Director of CFM
Can COVID-19 Translate to Opportunities for Mexican Healthcare?
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More about this person Q: How much has CFM’s work been reshaped by the general changes in the sector and overall political climate in the country?
A: From our perspective and that of our pharmaceutical laboratory members, we have a firm commitment to the country. This refers to the long-term focus on R&D to contribute with more therapeutic innovations for the medical community and for the benefit of the population’s health. Along the way, we evaluate and adapt the necessary changes to provide continuity to the constructive relationship with the government.
Q: How does the promotion of R&D initiatives contribute to retaining Mexican talent?
A: Encouraging talent is a path we have taken to strengthen the scope and installed capacity of companies with the knowledge that the academy offers. This is also supported by close collaboration with institutions and the impetus of talent seeking more opportunities to contribute to health solutions and improve the quality of life of the population. It should be noted that the national pharmaceutical sector, in addition to creating thousands of jobs annually, continuously implements programs to ensure talent is better prepared in their respective areas.
Q: What can Mexico do to start developing more technology and science on healthcare?
A: Globally, the incentives that governments create and offer to pharmaceutical companies are the key to growing technological platforms, R&D and speeding up the process for new medicine development. This is a virtuous cycle that requires the modernization of regulatory processes in institutions to benefit more patients. In this sense, Mexico and its regulatory bodies must be in tune with their global peers.
Q: What measures has CFM taken to address the COVID-19 crisis?
A: Several CFM companies are conducting clinical trials of new products to combat COVID-19, which we hope are successful. On May 17, 88 intensive care Shangrila 510s ventilators arrived to Mexico from Shanghai, which were jointly acquired by the Mexican pharmaceutical laboratories Silanes, Carnot, Liomont, Sanfer and Chinoin, in alliance with the Carlos Slim and Grupo México foundations. These were donated to the benefit of 11 hospitals and health and charitable institutions that combat the COVID-19 pandemic. This group of companies and foundations was coordinated by CFM, with the support of the INCIDE (Innovation and Science for Business Development) Foundation and following an agreement reached with the IMSS Foundation.
Q: How could API production help Mexico position in the pharmaceutical production market?
A: The country needs strategic mechanisms between the government and the pharmaceutical industry to promote national API production and reduce the dependence on China or India, which together cover around 80 percent of the global API market. Even the US is actively promoting this route, which makes this an ideal time for Mexico, the US and Canada to promote medium and long-term commitments between companies and governments to create certainty for investments.
Juan José Aguirre
Commercial Director of Grupo Bruluart
Strong Portfolio Helps Deal With Disruption
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More about this person Q: What is the reach of your distribution services for independent pharmacies?
A: We have distribution centers, called Medicine Depot, that work like a wholesale shop. Independent pharmacies can supply customers after proper registration and following our authentication process. These shops allow us to cover the entire country.
Q: What other market niches has Grupo Bruluart identified in 2020?
A: Hypertension is a growing trend in Mexico. We only have a few products directed to that ailment but we are starting to address it. Sexual health is another growing trend. Contraceptive use has increased a great deal as a result of the change in societal mindset. Grupo Bruluart has been working on campaigns to prevent unwanted pregnancies and we are working on a stronger communication strategy to announce our products.
Instead of being a medicine provider, we are a health provider. Our efforts our focused on seeing medicine as preventive rather than corrective. Through digital platforms and physical magazines, we distribute information and advise patients on living healthy lifestyles.
Q: How has the use of technology in logistics helped the company to face the COVID-19 crisis?
A: Our mindset shifted to a digital vision, which has led us to integrate more technological tools to help make our logistics more agile. We created a business intelligence department a year ago. Through it, we had been able to use data in our favor. The initiative is still pretty new so there is little historical record to base on, but we are already working on creating a robust database to, in the future, be able to make better predictions and build intelligent business strategies to be more purposeful.
Q: What has been the reception of Bruluart’s multivitamins given the fact that Mexicans are not very health-focused?
A: Our advantage is that Grupo Bruluart’s products are almost a reference in Mexico. Products are known by name, not as a “supplement” or a “multivitamin.” Such is the case of Tribedoce. This has become a referent for different ailments or discomforts and this is the result of our work in the market. We have one of the strongest facilities for injectable product manufacturing in the country and this has secured product supply at all times and helped with promotion. For Tribedoce we did not have to create a massive promotional campaign since the product is wellknown and always available. We have started to receive requests from the US to test Tribedoce.
Q: What are the company’s strategies in terms of growth?
A: Because of the uncertainty regarding the public sector, we have been focusing on the private sector, betting on a new growth strategy for our pharmacy chain because it has been growing organically. Investing more in it will strengthen its development. We are also interested in supporting independent pharmacies through or distribution services.
Rodrigo Hernández
Director General of Quimpharma
Despite Regulatory Changes, Communication Channels Must Remain Open
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More about this person Q: How has Quimpharma’s business evolved throughout the years?
A: We have three business lines in the medications area: oral liquids, non-oral liquids and pills. We have also ventured into traditional capsules. In the supplements and cosmetics area, we offer capsules, pills, creams and solutions. We are gradually shifting toward solids in the area of medications. Our production capacity will be further expanded with our intention to build a new plant next year. The idea is to open this facility in Mexico City. We are focusing most of our investment there, with the rest allocated to developing the best active ingredients for our products.
Q: What is your perspective on the government’s agenda?
A: The government is attempting to change the rules in different ways. I understand there is a need to guarantee medicinal supplies and I believe the Mexican industry is capable of supplying high-quality medications at the required volume and at competitive prices. The more complex part is distribution. The government is now going directly to laboratories to purchase medications. There is a risk involved in this, as laboratories need to learn how to conduct sales procedures. Eliminating the middleman introduces other challenges too. We have high standards for medication transport and distributors ensure these standards are always met. We are also used to including distribution in our price calculation. Nonetheless, we will adapt to the condition established by the market. Generally, changes in government purchases do not affect us that much because 85 percent of our clients are from the private sector. Currently, you see more laboratories trying to expand their portfolio in the private sector to safeguard their business. We have the benefit of knowing how to operate in this sector already.
Q: What is the state of generics manufacturing in Mexico?
A: Many laboratories are working hard to meet COFEPRIS’ new demands. A lot of pressure is being applied to eliminate any form of corruption. We are all for that. However, at times it has led to delays, from authorities, which paralyzes the industry. There should be strong cooperation between the sanitary and health authorities and the laboratories to ensure that innovation and new developments can continue. This is foremost dependent on transparent communication channels. The desire to rectify things is understandable, but those channels between the manufacturers and COFEPRIS have to exist.
Q: How has the epidemic affected your supply and distribution lines?
A: This is a major problem. Derived from border closures in several countries, the supply chain has been disrupted. At the same time, the public sector has been unable to handle the pressure of the pandemic which has resulted in increased waiting times regarding regulatory procedures. Communication is key to face this situation. Public medicine purchases have also been greatly delayed and given the difficulty of importing raw materials, along with challenges regarding distribution, it becomes vital to accelerate regulations to not jeopardize the timely supply of medicines.
Efrén Ocampo
President of Grupo Neolpharma
Investment Responds to Patient, Market and Industry Needs
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More about this person Q: Grupo Neolpharma recently inaugurated its distribution center and production plant for plastic vials in Vallejo. How does this reflect the company’s commitment to the sector?
A: Grupo Neolpharma’s high production rates, coupled with the new centralized purchasing schemes from INSABI that gathers supply from different states and institutions, meant we needed to have more efficient orders and deliveries.
Last year, we began the construction of a production plant for plastic vials from 1mL to 50mL. We realized the offering for this product was lacking despite its low production and packaging costs, not to mention the advantage derived from eliminating the dependency on glass. To date, glass vials are a barrier as the melting processes can endanger the condition of injectable solutions.
Grupo Neolpharma now has a plant for injectable oncological products, one for specialty analgesics and one large-volume plant for injectables focused on distribution to the US, plus our distribution center. We know that the US has a fragmented offer. However, we are familiar with its market from the experience we have with our plant in Puerto Rico.
Our injectables plant in División del Norte has the capacity to produce around 50 million vials per quarter, 16.6 million vials each month. This enables us to serve large orders when needed and be a strong competitor for vaccine production. Moreover, our level of distribution has increased with the distribution center, which allows us to take advantage of quick delivery opportunities.
Q: What is the status of Grupo Neolpharma’s initiative to introduce pain medications for conditions like terminal cancer?
A: These products will be manufactured at our specialties’ plant, where we produce analgesics for intense pain. Our plant for oncological injectables also responds to these needs and it will start operating by the end of 2020. Mexico has a large demand for oncological products and we are proud to contribute to reducing the negative impact of this disease.
Q: Why is Grupo Neoplharma the right partner for UNAM and its COVID-19 development?
A: We have worked with UNAM research centers for years now. We have two patents that began at UNAM’s facilities. This institution, along with CINVESTAV, has been working on vaccine development for a while. From our side, as part of the objectives for our production plants, we wanted to introduce biotechnology and APIs from bacteria and cells. Putting this together, we created a link with these institutions to help them accelerate their development processes to manufacture vaccines. We are also working on the development of the correspondent APIs for production.
Q: What are Grupo Neolpharma’s near-term plans?
A: We want to grow internationally and to increase our API production for Mexico by collaborating with institutes that are developing petrochemicals, which are an important base for API production.
Benjamín Vega
Commercial Director of Allen Laboratorios
Strong Product Mix Allows for Competitive Quality, Price
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More about this person Q: How has Allen Laboratorios positioned itself as a key player in the Mexican healthcare market?
A: To provide the best quality generics, we follow the strict regulations Mexico applies to the pharmaceutical industry. Moreover, from 2018 to today, we have invested more than MX$200 million (US$9.9 million) to strengthen our production plant, which has allowed us to diversify our market from the public to the private sector. For the latter, we have looked for commercial partners among retailers, self-service stores and pharmacy chains to strengthen our presence and grow. In addition to expanding our market options, with this investment we went from manufacturing 3 million units per month to now having the capacity to produce 8 million units per month.
Q: In which areas are Allen Laboratorios’ strongest market niches?
A: Retail and self-service stores have become our strongest market niches through our proprietary brands. Pharmacy chains also represent a large share of our sales as we work with the largest companies in the country. Moreover, we are present at Farmacias Similares, which is a big reference in volume consumption. These three channels complement our supply to the government.
Q: How is Allen Laboratorios able to provide quality, accessible generics that respond to specialty treatments?
A: When growing our production plant, we took some risks regarding long-term negotiations for raw material supply to guarantee competitive prices and affordable costs. Moreover, we targeted the products that were having the most impact and best performance in the market regarding volume sales and focused solely on those.
Q: What new market niches have you identified in the past year?
A: We want to focus on regional or local chains to target consumers directly, instead of through larger distributors. Allen Laboratorios is also looking forward to dabbling into the Central American market. We offer basic products that would perform just as well there as they do in Mexico and we are already finding ways to enter that market. Moreover, regulations from Mexico are a reference for the region, meaning that we would not struggle on that subject at all. The products we are looking to strengthen are our analgesics, supplements and cough suppressants. One of our best-selling products is Gerial B, which is constantly undergoing a brand renewal process and continues to have the same success.
Q: What has been the impact of changes in the public sector on the Mexican industry?
A: Government changes have brought uncertainty to the environment to the point of impacting the nation’s healthcare due to shortages. However, the intention is good and we are more than ready to keep doing things correctly. Allen Laboratorios decided to strengthen its internal processes to understand our capacity and profitability to supply the government in a timely manner and in full.
Rafael Quintanilla
Pharma and Biologics Director of Laboratorios Silanes
Innovation is Only Worth It When Giving Back to the Patient
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More about this person Q: How is the company transforming the healthcare reality of the population regarding diabetes?
A: Laboratorios Silanes is celebrating its 77th anniversary this year. Throughout our history, we have focused on innovation that is aligned with the healthcare needs of Mexico and with our capacity as a company. Diabetes and metabolic diseases are the most relevant and represent around 40 percent of our revenues. To date, the most remarkable achievement of our participation in the market is our patented pharmaceutical development of glimepiride and metformin, which we licensed to companies like Sanofi. This product has not been matched in its effectiveness, making it our flagship solution. We are developing a similar combination and a new molecule is already in the registration process. Unlike other companies, Laboratorios Silanes is focused on constant innovation.
We are global leaders in metabolic disease treatments and preventive treatments for diabetic complications. We measure success not by profit but by the true impact products have on changing people’s lives. We often look for commercial partners like Sanofi that have a global presence and can help us reach more patients.
Q: What other examples can you offer regarding Laboratorios Silanes’ innovative contributions to healthcare?
A: We have a business unit dedicated to antivenoms. Labratorios Silanes is a global leader in the subject and the only Mexican company with two FDA-registered products. One of them is an anti-scorpion bite serum and the other is an anti-rattlesnake bite serum. Both products are being commercialized in the US, which is a unique step for our company. Last year, we also developed an antivenom for violin spider bite and it already has gone through basic approval processes.
We are working with WHO to tackle snake bites, which cause the death of 120,000 people and 400,000 amputations around the world every year. WHO started a project 18 months ago to reduce the number of fatalities to at least half. The organization started looking for allies to supply 3 million doses of the serum. Laboratorios Silanes is among the three companies participating in this project, which we are very proud of because it is an example of our efforts on innovation and our true commitment to contribute to healthcare.
We dedicate 10 percent of our earnings to R&D because innovation has been key to the sustainability of the company. Laboratorios Silanes has 147 registered patents and 18 months ago, we decided to invest MX$100 million (US$4.398 million) in our research center in Toluca. This allows us to have a pipeline of 18 products for the coming year. They are all at different stages but they are the engine for our growth and expansion.
Q: What are Laboratorios Silanes’ priorities and growth expectations for 2020?
A: We are launching a product to lower cholesterol. This product is the most effective on the market, which is why, despite the contingency, we decided to release it. The benefits are significant. Additionally, we are still expecting double-digit growth because we have been working at the same pace, with the same effort and also launching this new product.
Américo García
Director General of Mexico and Latin America at Apotex
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More about this person Q: How is Apotex innovating to attend the growing prevalence of chronic diseases in Mexico?
A: At Apotex, we have a portfolio with a wide variety of products for several chronic diseases, including diabetes, arterial hypertension, high cholesterol and triglycerides and metabolic syndrome. We are committed to raising patients’ quality of life by offering affordable products that meet the highest quality standards. This is precisely why we are constantly striving for innovation, not only in our product portfolio but also in our communication channels. Entering the digital world to reach more patients means providing better solutions for their health problems, as well as creating a support network that ensures proper treatment completion.
Q: How would you describe the reception to Apotex’s cardio-analgesic portfolio?
A: Given that Apotex meets internationally recognized quality standards, specialists are highly welcoming of our cardio-analgesic portfolio. Apopharma (Apotex’s prescription division), is now highly recognized by traumatologists, internal medicine specialists and general physicians, who are the main prescribers of these kinds of treatments. Along with our central nervous system portfolio, cardio-analgesics will be an important business segment for Apotex in the foreseeable future given the epidemiological trends affecting the Mexican population.
Q: What other therapeutic areas is Apotex targeting and why were they chosen?
A: Other therapeutic areas that are being analyzed are gastroenterology, metabolic syndrome and oncology. There continues to be a high incidence of metabolic diseases such as diabetes, hypertension and hypercholesterolemia in Latin America, which is why we will be introducing several high-quality therapeutic options at affordable prices in the region. Cancer is also prevalent in Latin America, which has led to a rise in the demand for oncological drugs. In the next five years, our goal is to introduce a variety of oncological generics.
Q: What new market niches have you identified?
A: Over the past three years, we have explored branded market segments such as OTC and prescription medication. The Apopharma division is an excellent example of our effort to introduce prescription alternatives that can efficiently support specialists and physicians in general. Regarding the OTC segment, Espadiva is consolidating as the leading treatment option for menstrual cramps.
Q: What is the status for production of biosimilars in Mexico? What challenges has the company faced to introduce this division to the country?
A: Undoubtedly, biosimilars are a business opportunity and one of our major priorities. Apotex has created Apobiologix, a specific division to enhance our worldwide presence in this market. As a result, we have launched two biosimilars in Canada: Filgrastrim and Pegfilgrastim, indicated for patients with cancer receiving myelosuppressive chemotherapy. Similarly, we are looking forward to launching important biosimilar products in Latin America.
MS Nagendra
Director General of Zydus Pharmaceuticals
Market Strategies to Capitalize on Pharmaceutical Opportunities
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More about this person Q: What are Zydus’ most recent introductions to the Mexican market?
A: We conducted phase 3 of clinical trials in Mexico for Lipaglyn (saroglitazar Magnesium) to treat Non-Cirrhotic Non-Alcoholic Steatohepatitis (NASH). NASH is a progressive disease of the liver caused by metabolic disorders and a significant unmet medical needs. During clinical trials, we recognized the potential this product had as the only drug developed to treat such an ailment. We completed phase 3 of clinical trials and Mexico took part in the process. Zydus has already got DCGI approval for this one-of-a-kind drug in India and we are also looking to gain its approval in the US and Mexico. Once we get the NASH approval in Mexico, we will introduce it to the country as soon as we can.
Q: How is Zydus capitalizing on the biosimilar market opportunity in Mexico?
A: We are in the process of registering biosimilar products in Mexico. However, in the last couple of years, COFERIS has a long gestation period for its approvals and this has delayed our process of introducing such a portfolio to the country.
Q: How has Zydus advanced on its plans to introduce vaccines to Mexico?
A: Vaccine introduction is one of our most import global goals. The global vaccine market is around US$60 billion and Zydus has positioned itself as an emerging global player in this market. We have a unique distinction already: we are the first Indian company to launch a tetravalent vaccine in India. We are the second company to launch a TD vaccine. Now, we are among the few companies in the world working on a COVID-19 vaccine development. Zydus’ development is called “ZyCoV-D” and it has already entered Phase 2 clinical trials. If Phase 3 is completed by 2021, we have the ability to launch it fairly quickly. Mexico is an important participant in Zydus’ research and we have established a very positive relationship with the country. We are running two trials for COVID-19 in the country, both representing a substantial investment in terms of R&D.
Q: You have recently allied with the government of Hidalgo to be part of a pharmaceutical cluster. Why was this project of interest to Zydus?
A: We try to be meaningful players in the countries where we are present, which is why we are interested in collaborating through positive actions that boost the industry. Zydus tries to leverage its strengths in areas of market needs. For instance, Mexico has gaps to develop complex technological solutions for things such as injectable devices, so Zydus plan to fill in those gaps and improves access to those solutions. In CNS, Zydus has successfully introduced many products that could be very beneficial to the Mexican population. For complex generics, Mexico’s regulatory framework involves long approval times regardless of the good history of the product in the recognized reference countries. Regulatory barriers can sometimes hold us back from introducing products to Mexico and this is discouraging, considering the investment and technology solutions we can bring to the country.
Vincenzo D’Elia
General Manager of Laboratorios Alfasigma
A New World Ushers in New Trends
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More about this person Q: What is Alfasigma’s focus for the Mexican market?
A: We have set a budget to strengthen our R&D capabilities at our facilities near Rome. Having said that, Mexico can be involved in many of those projects. We shifted our focus toward specialty products and rare diseases because it is a highly profitable segment and there still many unmet medical needs. Thus, these segments could provide interesting ROIs and play an important role in needed new medical weapons to treat these diseases. In addition, this approach allows Alfasigma to focus more on specialists, such as cardiologists or gastroenterologists.
Mexico plays a relevant role as we represent one of the most important subsidiaries within our organization. Whenever a new product or license is released, Mexico is among our priority countries. There are many opportunities in the country, particularly in the health sector where there is fertile soil for new products.
Q: How has Alfasigma’s approach to the public sector changed since 2019?
A: We are not actively involved with the government as a supplier. However, we have been paying close attention to certain public institutions specialized in specific treatments, given the role they play in the education of specialists. Having said that, after almost two years in office, I cannot say innovation is a priority for the federal government. I believe its approach is more focused on providing medicines for all rather than have the latest innovation to the general population. The federal government has not shown any signs of giving R&D the importance it deserves.
Q: What has Alfasigma done to cope with the effects of the pandemic?
A: At Alfasigma, our No. 1 priority is our collaborators’ health. From the beginning of March, we started to implement all necessary measures to protect them. As a socially responsible company, we have supported many nonprofit initiatives to acquire the necessary equipment to protect patients. We have also focused on medical personnel’s mental health because they are being subjected to a high level of stress.
Q: What role are digitalization and data-related solutions playing in Alfasigma’s strategies?
A: The world will never be the same. The pandemic is accelerating existing trends, particularly the use of digital platforms, home office, state-of-the-art technologies and customer interaction. A key area where we will see greater developments is in automation. We are just getting started. As part of our local initiative, we are aware that the world is moving in a greater technological direction.
At Alfasigma, we are using data tools to conduct internal audits and spot trends. We have yet to see the results of this initiative, but I can tell you that management is the art of anticipating. If we can understand how the future might look, we can develop the right approach. I am confident of the steps we are taking.
Esteban Abad
Vice President and Head of Upper Latin America at Glenmark
Innovation Key to Remaining Competitive in the Generics Industry
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More about this person Q: How has the demand for your products behaved during 2019-2020?
A: We have a global best-case in Mexico with one of our respiratory products, which is a combination of our topselling antihistamine and our top-selling antileukotriene. This combination is unique in Mexico and has enjoyed a solid performance in the country because it tackles both root causes of allergic rhinitis. This is a prescription-only product, so the role of doctors is key here. However, the results are evident and doctors are confident in prescribing it.
As a respiratory product powerhouse, we are constantly innovating to keep building the company. Glenmark is focused on creating new formulas that can be a watershed for patient treatment, such as that previously mentioned. We are expecting to introduce a differentiated product for allergic rhinitis that is already awaiting COFEPRIS approval. We are investing in digital tools that will allow us to have direct contact with doctors and be able to communicate and launch this product in the market.
Q: How does Glenmark take advantage of the highly competitive and fast-growing market for generics in Mexico?
A: Our strategy is to create a differentiator for each product we launch. Many companies can participate in the market but not all of them have a strong scientific team to dabble in new formulas or combinations. Mexico could become an important player like India. However, the US, the biggest market for the country, is not interested in reformulated combinations because the FDA does not take a positive view of these. Their market is strictly ruled by new molecules, which could be a reason why Mexico has not fully developed in the area.
Q: What is Mexico’s potential as an API manufacturer?
A: It has been said that Mexico could become an API producer but it is not that simple. While we might have manufacturing capabilities, there needs to be a specific demand to fully develop them as the infrastructure required for a single API is not cheap. It ends up being easier to import from already expert countries. For Mexico to become an API producer, demand would need to be global, such as India’s. Only then would it be a profitable business.
Q: What has been the impact of the pandemic on your product demand in Latin America and Mexico?
A: In Mexico, we have been facing a drop in sales. Around March, most therapeutic products, especially for respiratory conditions, grew in demand and companies started to build inventory to prepare for when COVID-19 arrived to Mexico.
Our stronger business lines are respiratory and dermatology. Especially in the latter segment, these are not critical illnesses that people tend to prioritize. However, I think we have already seen the worst of it and we expect sales in Mexico to recover soon, but not quickly enough to put us back at pre-COVID-19 levels. The branded generic industry is better placed in terms of recovery because of the more accessible prices it manages.
Lourdes López
Executive Director of ANADIM
PharmacyAdjacent Medical Offices Can Expand Health Coverage
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More about this person Q: What has been the most significant benefit for patients from pharmacy-adjacent medical offices (PAMOs)?
A: We have 4,500 PAMOs across the country, which deliver more than 130,000 consultations per day. The biggest benefit is the convenience the population derives from them. PAMOs provide quality and affordable healthcare access through welltrained, qualified doctors. ANADIM’s PAMOs cover significant patient needs, especially now, given the workload that hospitals are facing due to the COVID-19 pandemic.
We work closely with the General Health Council and one of our main objectives is to continuously improve the quality of PAMOs. We are doing this through certification of quality processes. We are also interested in working alongside the Ministry of Health to collaborate on the provision of healthcare. PAMOs are an important contributor to the sector due to their capacity and how they support the industry’s workload. We would like to work alongside the government as a medicine distribution center and to have our facilities provide greater coverage and expand capacity.
PAMOs are also an option as vaccinating points due to the large number of facilities available. We are approaching the government in this regard to create a positive health environment that generates added value for the industry.
Q: Why was it important for ANADIM to establish an ethics code for PAMOs?
A: The ethics code is a way to homologate how PAMO doctors behave with different entities, including patients, the pharmacy employer and pharmaceutical laboratories. This code serves as a guideline that allows service to be transparent and clear. It was drafted alongside ANTAD and the General Health Council to demonstrate our joint objective to improve service quality.
Q: What are the main benefits doctors receive from working in PAMOs?
A: Among the main benefits is that they have a space for business and a guaranteed salary. PAMO doctors are employees of the pharmacy, meaning that regardless of the workload, they receive a salary.
Q: How can PAMOs help expand health coverage in Mexico?
A: PAMOs are oriented to primary care; however, we understand the need for Mexico to expand medical care for chronic diseases. In this sense, we are looking forward to fomenting preventive healthcare to avoid developing ailments that represent a burden on the public health system.
Q: What are your experiences as a female leader in the healthcare industry?
A: I think this sector is very open to equal gender participation. I have never felt gender inequality regarding opportunity and development and my voice in the sector has always been heard. I have been able to work with many women who are also in leadership positions, so I see this sector as a place where women have the opportunity to grow.
Ignacio Merino
Director General of Farmacia París
Evolution Needed to Strengthen Pharmacy Business Practices
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More about this person Q: Why should people consider Farmacia París as their first and best option?
A: Farmacia París is known as the pharmacy of the people. We are not a pharmacy that offers non-trademarked medicines at a discount. We sell brand-name, quality products, at the best price. We offer the widest range of products sourced directly from top laboratories and manufacturers. We work hard to offer unique services, like compounded formulas or shipping across the country. Ultimately, we care about the wellbeing of our customers. That is why we honor with fidelity the prescriptions written by physicians.
We strive to be an ethical business enterprise. Today we are the only pharmacy in the country that offers Ayurvedic medicine.
Q: What are Farmacia París’ strongest areas and what other areas does the company want to strengthen in the near future?
A: Our biggest strength is the relationship we have with our partners and customers, such as laboratories, suppliers and manufacturers. Some relationships go back many decades and in some cases many generations. Our second most important differentiator is our beauty and personal care offering, because we believe in helping our customers cater to their own well-being. Thirdly, I can highlight our range of surgical and hospital products to support both public and private medicine practices. Our diabetes division will also remain as one of our most important divisions for the next 20 years, as Mexico’s diabetes crisis continues to balloon.
Q: What is Farmacia París’ growth strategy?
A: The sector is evolving from being a traditional retailer to a business focused on customer experience. Farmacia París is transforming according to that trend. We are working on alliances with Laboratorio Medico Polanco, to offer on-premises clinical tests and lab-work. We are partnering with Óptica Devlyn to offer audiology and ophthalmology services. In the near future, we are also looking to incorporate general medicine offices through a partnership with a select group of doctors.
We are excited to announce that in the second half of 2020, we will launch Farmacia Paris’ e-commerce website offering 5,200 products from our catalog. We aim to reach every corner of Mexico City serving about 10 million people. Moreover, through Farmacia Paris’ e-commerce platform, we will be able to reach customers in the whole country.
Q: How would you describe the general state of the pharmaceutical sector in Mexico?
A: The pharmaceutical sector is changing its business model and so are the laboratories. In time, pharmacies as we know them will disappear and will be replaced by points of sale of mostly OTC products. Specialized products will be managed differently, which is why I do not think that opening more brick-and-mortar branches is the best option. Also, from a regulatory perspective, COFEPRIS will require an even more regulated point-of-sale.
Gabriel Zavala
Commercial Executive Director of Farmacias del Ahorro
Client-Centric Portfolio Strengthens Leadership Position
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More about this person Q: How do you balance price with quality to remain one of the most competitive pharmacies in Mexico?
A: Farmacias del Ahorro (FAhorro) is committed to offering fair prices for services and products. Our services go beyond selling medicines. One of our top achievements has been our leadership in supplying complete prescriptions due to our large and homogenous offer. We have the most complete portfolio in the medicine retail market. Moreover, we offer free medical consultations and an electronic wallet where clients can accumulate money. FAhorro’s home delivery service is also free of charge and our broad coverage makes our health service widely available. This integral offering has made us a leader among pharmacies and a success story in Mexico.
We have an effective reorder system that customizes our supply for each pharmacy according to its needs and trends. Our clients build our catalog, which means we are responding to patients’ needs based on demand. We are looking forward to expanding our presence where there is opportunity to grow and position FAhorro as the best-known and relevant pharmacy chain in Mexico.
Q: How does FAhorro contribute to increasing prevention and decreasing the disease burden in Mexico?
A: Our pharmacies are based on four main pillars. The first is correction, which focuses on medicines. The second pillar is drive, which includes our hygiene, beauty, dental care and drinks. The third is the emotive pillar, which includes dermatological care. The last pillar is prevention, which promotes preventive healthcare.
Three years ago, we launched a project to introduce healthier products, such as snacks, organic vitamins, dietary products and supplements, as well as other products that go beyond being sugar-free and that are organic and healthy options for the client.
Q: How are FAhorro’s pharmacies transforming to meet technological and digital demands?
A: We started with home deliveries and our digital platform before COVID-19. We have a department working on this service, instead of depending on another company for it. Thanks to this experience, we have been able to improve our service offering. We can ensure deliveries within 30-60 minutes and we are working to improve those times. FAhorro has also launched its own app because we understand that the digital transformation accelerated with COVID-19 and is here to stay.
Q: What is the most significant challenge that FAhorro faced during the COVID-19 pandemic and how did you overcome it?
A: We faced increasing demand for a group of products. Manufacturers of such products would significantly increase the prices on those supplies and due to the high demand and prices we created strategies to keep our offering affordable. Over time, we established strategies be independent of third parties and continue supplying to our clients. We continue to reduce the price for this product, despite increases in the cost of raw materials.
Santiago González
Operations Director Mexico of Farmacias YZA
Pharmacies Grow Their Role as Health Providers
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More about this person Q: What are the benefits and disadvantages of having a doctor’s office adjacent to a pharmacy against traditional offices?
A: Pharmacy offices offer three advantages to users. The most obvious is convenience, since they offer proximity, long hours and short waiting times. The second advantage is the low cost. The fee of a single visit is low and prescriptions usually refer to active ingredients instead of brands, which benefits the user economically. The third advantage is their level of service. Independent and serious surveys give pharmacyadjacent offices the highest level of customer satisfaction, at the same level as traditional private offices.
The main pending that is necessary to work on with pharmacy offices is to improve their reputation as they offer hundreds of thousands of daily consultations and they are normally the first point of contact with the patient thanks to their wide coverage.
Pharmacy offices can also do more in terms of prevention and timely detection of chronic diseases. The easiest thing is to train doctors and establish protocols. However, the challenge is for the user to see these places as an option for prevention and care.
Q: What is your opinion regarding doctors’ wages in these establishments?
A: As president of ANADIM, I collaborated in developing and promoting a code of ethics that was endorsed by the General Health Council, CCE and ANTAD. The document specifies that doctors’ wages must be calculated according to their time and effort, never to the prescription, which I believe is met in most cases.
Q: What have you observed following the COVID-19 emergency regarding growth in telemedicine alternatives and access?
A: Telemedicine has grown significantly. Many doctors at the beginning of the health emergency canceled their medical consultations and only worked remotely. There is evidence of the great boost resulting from telemedicine, regardless of the age or profile of the doctor using this technology.
Unfortunately, consultations are offered with tools not designed for this work, with the most popular channel being WhatsApp. Today, there are many tools that save the clinical history or that help the doctor with the diagnosis. Regulatory changes are required to foster their use and to create awareness. Telemedicine is undoubtedly appreciated by a patient who cannot visit a doctor.
Q: What impact has the COVID-19 pandemic had on drive-through care and home service options?
A: During the worst months of the pandemic, these services doubled in demand. However, as people returned to their regular activities, growth has been limited. Many operational changes were required to support the increase in demand for these solutions.
