There is a significant discussion about public procurement based more on value than price to ensure product supply, including the debate on multiple awards versus the winner takes all principle, currently seen in Europe. The model based on European regulation for tender evaluation, “Most Economically Advantageous Tender,” incorporates other variables beyond price into the decision algorithm. In the current state of biosimilar development, a multifactorial value proposition is crucial.

Colombia faces a significant gap in local biosimilar production, highlighting the country’s dependency on imported biologic drugs. However, promising initiatives are emerging. The INC and IDCBIS, among other organizations, is spearheading efforts to establish local manufacturing capabilities. This strategic move aims to enhance accessibility to crucial biologic treatments, potentially reshaping Colombia’s pharmaceutical landscape.

The significance of local biosimilar production cannot be overstated in ensuring a nation’s healthcare autonomy. While the journey towards achieving this goal may seem daunting, success stories from countries like Brazil, Mexico, and Argentina prove it is attainable in Latin America. These nations not only manufacture biosimilars domestically but also export them, significantly enhancing access to vital therapies domestically and abroad. To propel Colombia’s industry forward, analysing these case studies is imperative. By understanding the challenges, support systems, and societal benefits these countries have experienced, Colombia can pave the way for a thriving local biosimilar industry.

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. The success of this initiative will play a crucial role in fostering the widespread adoption of biosimilars throughout Latin America.

In the realm of technology transfer agreements within the biosimilars sector (such as Brazil’s PDPs), international companies place significant emphasis on regulatory policies. These policies play a crucial role in ensuring compliance with local standards and requirements. Firms navigating this landscape aim to strike a delicate balance between fostering innovation and meeting stringent regulatory demands. Through strategic partnerships that align with local manufacturing policies, the focus remains on safeguarding the quality, affordability, and accessibility of biosimilar therapies, thereby contributing to the advancement of healthcare accessibility and affordability.

Exploring the achievements of the Cuban Regulatory Agency unveils valuable lessons for Colombia’s nascent biosimilar industry. This investigation illuminates Cuba’s successful regulatory strategies, showcasing their potential applicability to Colombia’s evolving biologics landscape. From efficient approval processes to the promotion of local manufacturing, these insights offer a roadmap for Colombia’s biosimilar sector to thrive and improve healthcare accessibility.

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