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Review
. 2025 Jun;25(6):633-647.
doi: 10.1080/14712598.2025.2507173. Epub 2025 May 29.

The potential role of biosimilars in healthcare sustainability in Latin America

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Free article
Review

The potential role of biosimilars in healthcare sustainability in Latin America

Rony Schaffel et al. Expert Opin Biol Ther. 2025 Jun.
Free article

Abstract

Introduction: Latin American (LatAm) countries face significant increases in healthcare expenditure, driven largely by population growth and aging, and the rising prevalence of cancer and other chronic diseases. Growing demand and high costs of biologic medicines present barriers to patient access in this region. Biosimilars can improve the affordability and accessibility of biologics, supporting long-term healthcare sustainability. However, their uptake in LatAm has generally been slow.

Areas covered: Challenges and barriers to the use of biosimilars and potential strategies to increase biosimilar uptake in LatAm, drawing on learnings from Europe and the U.S.A.

Expert opinion: Potential initiatives to drive biosimilar uptake across LatAm include (1) harmonized regulatory processes for biosimilars, with reimbursement policies that prioritize their use and incentives to encourage prescribing; (2) education for key stakeholders to limit misinformation about biosimilars, provide reassurance about safety and efficacy, and increase understanding and acceptance; (3) simplified health technology assessment processes for biosimilars that expedite or adapt some aspects of the traditional approach; and (4) coordinated regional efforts to enable national healthcare systems to purchase medicines in the most cost-effective way, with value frameworks to support decision-making and the implementation of centralized purchasing, competition policies, and risk-sharing agreements.

Keywords: Biologic; Latin America; biosimilar; cost saving; education; policy; regulatory.

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