Recommendations for Interchangeability in a Growing Biosimilar Market in Latin America.

Background: Biosimilars offer significant advantages for improving access to biologic treatments in Latin America. However, their uptake has been slow due to misconceptions, regulatory uncertainties, and inadequate pharmacovigilance.

Objective: To address these issues, Americas Health Foundation convened a multidisciplinary panel of regional experts in biosimilar use and interchangeability from Latin America. The panel assessed the current landscape and recommended steps to enhance access.

Results: Key recommendations include strengthening biosimilar regulations, ensuring transparent enforcement, implementing robust pharmacovigilance, and promoting collaboration among stakeholders to educate about the safety, efficacy, and economic advantages of biosimilars and their interchangeability.

Conclusions: By embracing biosimilars and interchangeability, Latin American countries can expand patient access, foster competition, diversify treatment sources, and enhance the sustainability of their healthcare systems. However, achieving these goals requires addressing knowledge gaps and biases among healthcare providers, patients, regulators, and government agencies. This can be accomplished through clear communication and the use of real-world evidence.