Colombia is building local biotech capabilities to reduce its dependency on imported biologics. This session explores how initiatives like those led by INC and IDCBIS are creating opportunities in infrastructure, talent, and local production, positioning Colombia as a strategic hub for biosimilars in Latin America.

Unlike the PDP Program, which focuses on building national capacity through technology transfer from private companies, the PDIL aims to reduce the production and technological vulnerability of Brazil’s Unified Health System (SUS) by fostering local development of innovative solutions. The Ministry of Health would select projects regularly submitted to the Secretariat of Science, Technology, Innovation, and Health Complex (“SECTICS”), as well as projects submitted in response to public calls. Support would be formalized through instruments aimed at promoting innovation. This initiative aims to bolster local production and technological development in Brazil’s healthcare sector,.including the advancement of biosimilars.

With abundant resources and human talent, Mexico is an attractive market for biosimilar investors. This session highlights how regulatory reforms, public-private collaborations, and fiscal incentives are creating a fertile environment for investment in this strategic industry.

Exploring how the intricacies of registering and marketing biological products in Brazil can serve as strategic advantages for global investors entering the Latin American market.

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 harmonizing 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.

The panel will explore the evolving dynamics of supply chain strategies within the biosimilars industry, particularly focusing on the shift from traditional nearshoring to newshoring. This discussion will highlight how regulatory harmonization and global collaboration are reshaping manufacturing, distribution, and market access for biosimilars. Key insights will be shared on how companies are leveraging these changes to improve efficiency, reduce costs, and strengthen their competitive advantage while ensuring compliance with international standards. The panel will also address the challenges and opportunities presented by this transformation and its implications for the future of biosimilars production in Latin America and beyond.

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