[Industry Update] The changing biosimilars landscape in Latin America

TTY Biopharma and the Mexican Pharmaceutical Institute share their insight on regulatory and market changes in Latin America around biosimilars

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Pharma IQ

In advance of the Biosimilars Commercialization Summit, industry experts Jose Carlos Ferreyra, President at Mexican Pharmaceutical Institute and Fabiola Santillan, Country Manager at TTY Biopharm, spoke with Pharma IQ about how the biosimilars landscape is changing in Latin America.


How important has the introduction of biosimilars been to broadening patient access to biologic medicines?

Jose: The introduction of biosimilars in Latin American economies is key for granting better and quicker access to biologic therapies. Even though there are still regulatory issues regarding the biosimilars approval procedures, there are already 8 biosimilars in the national formulary. Some of them have been gaining quick market share, whereas in other cases, the biosimilar has killed the therapy to a market value of almost zero, due to a bad market entry strategy.

Fabiola: Jose raises some interesting points. I would also like to say that biosimilars are important, from the perspective that they offer more affordable prices for patients. However, the view of some doctors is that there is a risk of counterfeits. Medicines of this type circulate, which in reality are bad copies of the original and that, therefore, put at risk the health of those who then consume them.


Do you feel there are any factors inhibiting the uptake of biosimilars in the Latin American region?

Jose: Yes, a lot of factors! Starting from intellectual property, Latin America’s patent agencies are not quite aware of which part of the biologic therapies is “patentable” and which are not. The regulatory agencies, on the other hand, have not implemented a proper and formal procedure to approve a biosimilar with regards to the comparison of the original biologic. This means biosimilars must undergo almost the same tests, documentation and procedures to get approval as for an allopathic antibiotic

Fabiola: Greater vigilance in the approval of biosimilars or biocomparables by the regulatory agencies is required to avoid aggravating the health of their consumers instead of curing a disease. This has happened with several of these medicines in some countries, including Mexico, where Cofepris had to revoke sanitary records that had already been granted.


How has the competitive biosimilar landscape changed in the Latin American region in the recent years?

Jose: Not as quick as we expected. Biosimilars entry has been slow, slippery at times. At the Pharmaceutical Institute we expected a huge boom on the biosimilars market values, but still yet to come. However, the key players for the biosimilars won’t be the international pharma; the market will be led by local companies who invest in research for these types of therapies

Fabiola: I agree, but the biosimilar market has grown significantly and more companies are joining this type of product portfolio. The marketing strategy depends on the laboratory; however, there has been an interesting biosimilar management process, a joint venture with the idea of increasing access to these medicines through licensing.


How have the regulatory guidelines on biosimilars evolved in recent years?

Jose: Regulatory efforts had been made and implemented, making it possible to happen. Yet, much work has to be done in terms of intellectual property, regulatory approval and institutional formularies access.

Fabiola: Although regulatory activity has progressed since 2009, it is necessary for each regulatory authority in each country to have a greater degree of responsibility, above all, to follow-up on authorisations for biosimilar medicines. World Health Organisation will be key to ensuring transparency and security when increasing entry of biosimilars worldwide, and the harmonisation of requirements between the different regulatory agencies. One of the key points is that biosimilars will continue to compare interchangeability with biotechnology since it cannot be measured like regular medicines through studies, but rather based on medical evaluation and particular studies that demonstrate the same efficacy.


Are there any nations which are leading the way, in terms of biosimilars, in the Latin American region?

Jose: Biosimilars are a reality almost everywhere, but we might think of México, Brazil, Colombia and Argentina as the leading economies.

Fabiola: Depending on the perspective, we could say that the regulations vary considerably from one country to another. Brazil, Argentina and Mexico have got regulations in place, whereas, other countries such as Bolivia and Paraguay are still in the process of developing laws. There are also different paths to follow for the approval of biosimilars. ANVISA stipulates two models: the comparative and the individual development mode. The first involves the use of pharmacokinetic and pharmacodynamic studies, as well as phase three clinical studies. The individual mode requires quality data and clinical studies. Even in Brazil several medications have not been approved yet. In Central America, the vast majority of states do not have regulations for biologics.


What are the top 3 things that should be considered when entering the biosimilars market in Mexico and the wider South American Market Place?


1) To have auditable data: Particularly, because México is a very complex public sector and is made up of 150 different public institutions, 33 different health ministers, providing healthcare coverage to over 120 million Mexicans.

2) To have a local partner: Over 2,000 distributors are registered to sell national formulary code drugs to the institutional sector, but only 20 of them account for 80% of the total market value.

3) To be patient and invest: International pharma companies sell to the Government, and their institutional sales are 10 or 20 times bigger than in the private sector. Centralised purchasers are made to plan the budget for over a year, so when they say “tomorrow”, it might mean 2021. One government (institutional) sales rep of a typical pharma company sells the same as 17 sales reps of the private sector. Invest in the people.

Fabiola: Other things to consider are:

1) There is an independent regulation in each one of the agencies, there is no homogeneity.

2) Special clinical studies will be required.

3) In Latin America, very little is invested in the development and modernization of the infrastructure to enable the use of these innovations. Many hospitals and health facilities still do not have modern devices and tools to treat patients or use this type of medicines