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Review
. 2024 Dec;41(12):4357-4368.
doi: 10.1007/s12325-024-02990-y. Epub 2024 Oct 9.

Recommendations for Interchangeability in a Growing Biosimilar Market in Latin America

Gilberto Castañeda-Hernández  1   2 , Manuel Antonio Espinoza  3   4 , Luis Eduardo Pino  5 , Mariana Rico-Restrepo  6 , Bianca Schiavetti  7 , Enrique Terán  8   9 , Valderilio Feijo Azevedo  10   11
Affiliations
Review

Recommendations for Interchangeability in a Growing Biosimilar Market in Latin America

Gilberto Castañeda-Hernández et al. Adv Ther. 2024 Dec.

Abstract

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.

Keywords: Biosimilar pharmaceuticals; Cost–benefit analysis; Health inequities; Latin America; Patient advocacy; Pharmacovigilance.

Plain language summary

Biosimilars offer an opportunity to expand access to crucial biologic treatments in Latin America by providing lower-cost alternatives when patents expire. However, adopting biosimilars has been slow due to misconceptions and regulatory uncertainties. To address this, experts recommend considering approved biosimilars as interchangeable with reference products, allowing for switching without compromising safety or efficacy, with the limitation of switching only once per year. To improve access, well-defined regulations, enforcement, and transparency from regulatory agencies are necessary, along with education for healthcare providers, patients, and other stakeholders to address knowledge gaps and negative perceptions. Improved pharmacovigilance systems and collaboration between stakeholders can help communicate the benefits of biosimilars and interchangeability. By embracing biosimilars, Latin American countries can expand patient access, foster market competition, diversify treatment options, and improve the sustainability of healthcare systems.

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References

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