Colombia has established itself as a leader in biosimilar regulation across LATAM—but its role doesn’t stop there. It is now emerging as a strategic platform for expanding biosimilar products throughout Latin America. In this final installment of our series, we explore how to capitalize on biosimilar expansion opportunities, which Latin American (LATAM) markets offer the greatest potential, and how Freyr can be your ideal partner to leverage them.

WHICH COUNTRIES OFFER REAL OPPORTUNITIES FOR BIOSIMILAR EXPANSION?

The rising demand for effective and affordable biological therapies is driving biosimilar growth throughout the region. Some of the most promising markets include:

🇧🇷 Brazil

With a robust public healthcare system and a well-defined regulatory framework, Brazil is one of the most mature biosimilar markets in LATAM. ANVISA has established strong approval pathways and is committed to integrating biosimilars into its healthcare system.

🇲🇽 Mexico

With a large population and a stronger role for COFEPRIS as a regulatory authority, Mexico presents significant opportunities for biosimilar penetration. The government is also actively promoting access to more affordable biological medicines.

🇦🇷 Argentina

ANMAT has worked to integrate biosimilars more efficiently into the public health system, with a focus on interchangeability and quality monitoring to ensure safety and efficacy.

🇨🇱 🇵🇪 Chile and Peru

While smaller in market size, both countries are adopting progressive regulations that support the inclusion of biosimilars in both public and private systems, generating promising growth prospects.

COLOMBIA AS A REGIONAL EXPANSION PLATFORM

Beyond its favorable regulatory framework, Colombia offers logistical, regulatory, and commercial advantages that position it as an ideal hub for expanding biosimilars to other LATAM markets.

Key Strategic Advantages:

Strategic geographic location: Colombia provides efficient access to key Latin American markets.

Trade agreements: As part of the Pacific Alliance (with Mexico, Chile, and Peru), Colombia facilitates exports to these countries.

Aligned regulatory framework: Processes conducted in Colombia are often valid in other countries, thanks to the harmonization of regulations with international standards.

Local production incentives: Government policies supporting local manufacturing make Colombia a strategic site for setting up operations.

WHY FREYR IS THE IDEAL PARTNER TO DRIVE BIOSIMILAR GROWTH IN LATAM

Freyr’s regulatory support extends beyond individual countries. Thanks to its regional presence and ability to deliver end-to-end solutions, Freyr helps companies plan and execute their growth across LATAM efficiently and strategically.

Freyr offers:

• Regulatory strategy advisory: Tailored to each country’s requirements, including registration pathways, clinical study needs, and local approval processes.
• Regulatory compliance: Support in ensuring dossier content, pharmacovigilance, traceability, and other essential regulatory elements meet approval standards.
• International expansion consulting: Planning for product lifecycle management and regulatory strategies for simultaneous or phased entry into multiple markets.
• Promotional material review: Ensuring scientific accuracy and compliance with local and international regulations for communications and marketing content.

IN SUMMARY

Expanding from Colombia into other LATAM markets is not only possible—it can become a competitive advantage with the right strategy. With local regulatory knowledge, a well-defined plan, and the proper support, such as that provided by Freyr, your company will be well-positioned to grow across the region.

READY TO EXPAND YOUR BIOSIMILARS ACROSS LATAM?

At Freyr, we help you navigate regulatory challenges and seize strategic opportunities in the region. Contact us today and start building your successful LATAM journey.