Biosimilars for the next decade in Latin America: a window of opportunity.

Introduction: Biosimilars are gaining popularity in Latin America (LA). The biosimilars market is expected to grow rapidly over the next decade as a cost-effective alternative to expensive patented biologics. The drivers for the growing demand include needs for affordable health care, the prevalence of chronic diseases, expiration of patents for numerous biologic medicines and the advent of artificial intelligence (AI). Countries such as Argentina, Brazil and Mexico have implemented regulatory frameworks for the approval of biosimilars as well as for investment in local manufacturing capacity, sale, and distribution. Some LA countries face challenges related to low quality institutional frameworks and deficient public policies for regulatory harmonization of these medicines.

Areas Covered: The aim of this article is to analyze the broad window of opportunity for biosimilars in LA (Brazil, Mexico and Argentina) in the next decade, considering their regulations and institutional quality, as well as an affordable cost for patients with chronic diseases and highlight the biosimilars approved in the three countries studied. Likewise, the future contribution of AI in the drug R&D process is considered.

Expert Opinion: Preparing the next decade of biosimilars in LA will involve improving international regulatory frameworks, institutional quality, investments and capacity in R&D (competencies, infrastructure, and AI).