Potential Regulatory and Commercial Environment for Biosimilars in Latin America.

OBJECTIVES: Biosimilars are increasingly attractive to payers around the globe because of mounting financial pressure. Many Latin American governments are developing abbreviated regulatory pathways for biosimilars. There are limited data regarding how certain regulatory agencies in the region plan to address biosimilar access. This study explores potential opportunities and challenges for biosimilar drugs in Brazil, Mexico, Argentina, Chile, and Venezuela.
METHODS: We conducted targeted literature reviews, followed by key informant interviews, to understand the expected regulatory environment for biosimilars. We also asked questions about the economic, political, and historical factors that could play a role in the extent to which biosimilar-specific pathways have been developed across countries to date, and will continue to evolve in the future.
RESULTS: Brazil has led the development of biosimilar regulation in Latin America, with two distinct pathways, one for more complex molecules such as monoclonal antibodies and a less rigorous path for simpler molecules such as pegylated interferon and low molecular weight heparin. Other countries have been slower to respond, in part because of the degree of emphasis within each country for the advancement of biosimilar regulatory standards. Signs of relaxed standards akin to those seen in Brazil's "individual development" pathway were found in other countries.
CONCLUSIONS: The example of the two-pathway system coupled with governmental prioritization of local manufacturing capabilities in Brazil should promote increased biosimilar utilization within the country. Assuming that the two-pathway system demonstrates success in Brazil, we hypothesize that other Latin American countries may adapt aspects of this "local" model for developing a regulatory pathway for biosimilars.