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

ABSTRACT

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).

KEYWORDS:

• Biosimilars
• Latin America
• regulations
• institutionality
• market
• windows opportunities
• patents
• AI

Article highlights

• Significant increase in costs associated with R&D of new biomolecules leads to a preference for biosimilars.

• Patent expiry generates a window of opportunity for biosimilars.

• Regulations and the quality of the institutional framework responsible for their enforcement in Latin America will be key to the growth of biosimilars in the next decade.

• The use of artificial intelligence can speed up processes and increase efficiency in the R&D phases of biosimilars.

• The speed of approval of biosimilars and their low costs are key for patients with fewer resources to have access to quality medicines.

Declaration of interest

The author has no relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript. This includes employment, consultancies, honoraria, stock ownership or options, expert testimony, grants or patents received or pending, or royalties.

Reviewer disclosures

Peer reviewers on this manuscript have no relevant financial or other relationships to disclose.

Additional information

Funding

This paper was not funded.