Biosimilars Promise a Brighter Future for Latin American Patients

At the beginning of April 2019, I had the opportunity to attend to the Biosimilars Latam 2019 forum event organized by Jack Leckerman. The event brought together the key players involved in this industry throughout Latin America, where they joined to discuss the future and challenges biosimilars have, from development to commercialization, across our continent.

Among all the topics addressed in the event, the main conclusion was that the discussion related to these products has changed dramatically from those had in previous years; in the past, the industry was discussing the regulatory framework and how the different regulatory agencies, from Mexico to Argentina, would regulate these new therapeutic options. Now, after the maturity of the laws and the construction of different regulatory pathways for biosimilars in most of the countries, the discussion has moved on to the different challenges that the industry, whether local or foreign, faces in commercializing biosimilars.

Moreover, attendees agreed that, with the approval and launch of new biosimilars after patent expiry for the main biologic blockbusters in the area, key stakeholders, such as the pharmaceutical industry, physicians, governments, payers, and even regulatory authorities, will benefit from the introduction of biosimilars.

In most of the countries, governments are promoting the introduction of the biosimilars, due in part to the constraints they face in paying for high-cost innovative biologics, in addition to controlling healthcare spending linked with the increasing prevalence of diseases like cancer, diabetes, and other chronic conditions.

Brazil has now completed 10 years of the program known as the Partnership Development Program, in which developers of biosimilars partner with local and government laboratories to conduct technology transfers with the aim of assuring that the government, in order to attend to the majority of the people covered by the Sistema Unico de Saúde, can purchase the products developed by such partnerships. The first group of molecules developed under the partnerships is now being launched, and now stakeholders are asking how to increase health coverage and access to assure the benefits of these biosimilars and the cost reduction they provide. The goal is that cost reductions will benefit the majority of the population and also preserve the competitiveness of the local industry.

In the case of Mexico, in contrast to Brazil, local developers of biosimilars do not have the support of the government, and there is no existing policy to support them. Some key local players participating in development are facing the challenges of a more competitive industry coming from foreign countries, while local entities are also trying to produce and launch their biosimilar portfolios. The developers are trying to gain market share and demonstrate the benefits their developments have through a deep understanding of the science, technology, and other advantages their own development processes may have over the originator; these companies are making a great effort in terms of collecting evidence to demonstrate the value of biosimilars to patients and medical community.

In other countries, such as Colombia, Chile, Peru, Paraguay, and Argentina, governments are allowing the registration of many foreign biosimilars through licensing partnerships, and the key challenge that biosimilar players are facing is the dramatic reduction of prices. While in other continents, the markets are facing biosimilar discounts of around 30%, Latin America is seeing a dramatic fall in prices, up to 50%, with a quick uptake for those who are first to negotiate with the key stakeholders, such as governments who control the majority of purchases or exert control in healthcare spending. Such pressures force payers to control drug budgets and increase access for the population through price reductions while balancing issues of safety and added value of new options. Some examples include recent government tenders and the quick introduction and market share gained by the first wave of biosimilars launched in those countries. Also, in Argentina, local biosimilar development players are taking an important role in the local market protected by the government and expanding to other Latin American countries, increasing the extant competition through commercialization or even development of manufacturing facilities.

Finally, in the coming years, we will see a dynamic market with many players moving between countries with different regulatory frameworks and health system compositions, all trying to survive deep price reductions while demonstrating added value through the development of more real-world evidence or benefits in product improvements. At the same time, we will see these players increasing patient access to medicines. In the end, patients will benefit from these market dynamics with the introduction of therapeutic options that can help to overcome the access disparities that our region currently has.