Enhancing collaboration between European biosimilar manufacturers and Latin American regulatory authorities is crucial for advancing healthcare accessibility. Strategies include fostering dialogue platforms, sharing best practices, and harmonizing regulatory frameworks. By promoting mutual understanding and alignment, these efforts facilitate efficient market entry for biosimilars, ensuring patients across Latin America benefit from safe and affordable treatment options.

In Mexico, COFEPRIS is currently undertaking a strategic initiative to provide regulatory certainty to pharmaceutical companies, enabling them to introduce medical innovations and drive productive development in the Mexican market. The 2022−2030 agenda aims to foster competitiveness, industrial and commercial growth, and ensure access to safe and high-quality healthcare products. The implementation of this strategy focuses on harmonising regulatory approaches with other agencies, involving the public, private and social sectors, and compliance with ICH guidelines, among other factors. This strategy enhances investor confidence and facilitates timely market access, positioning Mexico as an attractive destination for European producers looking to expand their presence in the region.

Brazilian Partnerships for Productive Development (PDPs) exemplify successful collaborations between local public and private sectors, but may also offer a blueprint for potential European biosimilar manufacturers. By leveraging government incentives and industry expertise, PDPs foster local production of essential medicines and vaccines, benefiting both parties. This win-win partnership enhances healthcare accessibility while presenting opportunities for European biosimilar manufacturers to expand into new markets.

In Latin America, the potential for Contract Manufacturing Organizations (CMOs) and Contract Development and Manufacturing Organizations (CDMOs) catering specifically to biosimilars remains largely untapped. While some local companies aspire to offer these services, dedicated biosimilar-specialized CDMOs are yet to establish a presence in the region. In Brazil, for instance, emerging demand beckons CDMO companies, yet transitioning to professional and validated scenarios poses complex challenges, including competitiveness and navigating intellectual property landscapes. Despite hurdles, the rise of manufacturing in Latin America promises lucrative opportunities for those ready to address associated challenges.

Latin America’s clinical development requirements for biosimilars can vary significantly across countries, in contrast with the Europe. Brazil, Mexico, and Argentina have established national regulatory guidelines, while Chile and Colombia rely on WHO guidelines. Despite differences, all countries emphasize robust comparative clinical studies to demonstrate biosimilarity. Harmonization efforts aim to streamline processes, ensuring efficient and consistent evaluation of biosimilar safety and efficacy across the region.

Argentina’s scientific achievements stem from strategic political decisions made decades ago, bolstering the country’s scientific infrastructure. Pioneering companies epitomize this commitment, propelled by private capital investment and government support. These synergies have fostered scientific innovation, establishing Argentina as one of the regional leaders in research and development, while nurturing a robust ecosystem for scientific advancement and local industries.

Latin America faces both challenges and opportunities in biosimilar market access. Brazil, Mexico, and Argentina lead in regulatory frameworks but encounter hurdles like pricing and reimbursement policies. Colombia’s tender-based system drives market competition, while Chile prioritizes cost-effectiveness evaluations. Despite challenges, these countries offer substantial opportunities for biosimilar penetration, driven by growing demand for affordable biologic therapies and advancing regulatory landscapes.

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