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Regulations Needed to Boost Mexico’s Biosimilars Market

Rodrigo Fernández - Teva Pharmaceuticals
Senior Vicepresident Latam and General Manager Mexico


Miriam Bello By Miriam Bello | Senior Journalist and Industry Analyst - Mon, 05/02/2022 - 08:41

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Q: How has TEVA overcome access challenges in Latin America, specifically in Mexico?

A: Our mission is to improve the lives of patients and become a global leader in generics and biopharmaceuticals. We want to provide the right products and make them accessible. We work closely with stakeholders, government institutions, pharmacies, distributors and clinics, both in the private and the public sectors to ensure that key actors get to know our products and understand their quality.

Latin America has diverse healthcare systems and we need to align our insights and value propositions to each country. We are broadening our portfolio through partnerships and innovation in a variety of key areas, including pain management, movement disorders and neurodegenerative conditions.

In Mexico, we are working with pharmacy chains, distributors and key institutions, such as INSABI, IMSS and ISSSTE, to ensure access to a larger population.

Q: How representative is Mexico among Teva’s multinational markets?

A: Teva is organized in three regions: North America that includes Canada and the US, Europe that includes Western Europe and some countries in Eastern Europe and the International Markets that includes the rest of the world. Mexico is one of the 10 most important countries in the international division and one of the key markets for data growth in the world.

While Mexico can be complex in terms of regulations and clinical trials, it is possible to take advantage of its strategic location if you know how to navigate the system. We have over 600 employees in Mexico and are highly committed to the health of the Mexican population. We are willing to collaborate with all key stakeholders in the country to make access to healthcare a reality.  

Q: In what areas is Teva investing in Mexico?

A: In Mexico, we invest in three business units: active principal ingredients (API), Manufacturing and commercial. TEVA AMSO develops APIs used as raw materials and manufactures them at our plant in Lerma, State of Mexico. The plant employs about 225 people.

We also manufacture pharmaceuticals at our plant in Guadalajara, Jalisco, employing over 80 workers. In the past five years, we have invested over US$50 million in pharmaceutical manufacturing.

Our commercial section employs about 300 people in Mexico and grew over 50 percent last year in sales and revenue. In the past three years, we launched 15 products. We have identified opportunities to improve patients’ lives and we have launched supportive care products to manage side effects related to oncology, pain and cardiovascular diseases, among others

Q: How did API production strengthen Teva’s operations during the COVID-19 pandemic?

A: The API unit is a highly sophisticated part of the organization that provides us with flexibility by producing active products to be elaborated into medicines in manufacturing sites, both of TEVA and of other pharma companies.  The proximity to a large market like the US also gives us numerous advantages. 

TEVA explored multiple ways to supply patients, hospitals, governments with products they needed during the pandemic. In Mexico, during the COVID-19 pandemic, TEVA was able to offer a variety of products, such as anesthetics for patients who needed to be intubated because of COVID-19 complications. Teva was an important partner during the health crisis thanks to our integrated approach to API manufacturing, logistics and commercial abilities in the region.

Q: Regarding biopharmaceuticals, what are your plans for the Mexican and the international markets?

A: Teva aims to have a strong presence in the generics market, but also prioritize other areas and develop new products. The company has invested over US$1 billion in R&D globally to develop products like Copaxone, which treats multiple sclerosis, and Austedo, a treatment for Huntington’s disease. We are launching the latter product in Latin America later this year and in the US it launched about 2 years ago.

We also launched Ajovy in the US, Israel, China and more recently in Latin America to treat chronic migraine, a disease that makes people suffer severe symptoms for multiple days, leading them to withdraw from normal life. We will launch this medicine in the next couple of years in Mexico. Teva is also planning to enter the biosimilars industry, which provides more alternatives for patients and healthcare systems to manage costs and reduce budgets.

Q: What barriers hinder the use of biosimilars in Mexico?

A: Some countries in Latin America have been using biosimilars for some years, such as Colombia and Brazil. In Mexico, review processes need to be clearer so the industry can understand the criteria it must follow to get these medicines approved. In late 2021, COFEPRIS joined the International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use (ICH), which will lead to the simplification of these processes and allow the field to progress.

Private and public institutions have also helped establish a path forward for their inclusion into healthcare systems. Teva aims to collaborate with patient associations and key stakeholders across the country for a better understanding of the patient´s journey.

Q: How did the digitalization boom that occurred during the COVID-19 pandemic influence Teva’s operations?

A: The pandemic accelerated the digital transformation of different sectors, including healthcare. For Teva, it meant an internal transformation in which we learned to use our physical spaces better and developed an online continuity business plan. We learned from digitalization but also noted that human interaction is important for team building, leadership and growth. We implemented several strategies so our employees could balance their private and work life during the crisis. We also interact with our customers through our digital channels to help them understand the specific processes to comply with legal regulations and privacy matters in the context of digitalization.

The key question now is how to preserve some of the practices and learnings implemented during the pandemic. We need to make digitalization part of our lives while also maintaining human interaction within the organization. We also need to balance face-to-face and virtual meetings with customers. Finally, we need to take advantage of telemedicine to offer patients more access to healthcare. Governments and private institutions need to collaborate to make the telemedicine transition possible, which will benefit more patients. Healthcare will improve if every actor works together within an ethical and integral framework.


Teva Pharmaceuticals is an Israeli multinational specialized in generic medicines, APIs and proprietary pharmaceuticals. Teva is the 18th-largest pharmaceutical company in the world.

Photo by:   Teva Pharmaceuticals

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