BIOSIMILARS IN COLOMBIA: REGULATION, STRATEGY AND EXPANSION IN LATAM
Part 1: From Regulation to Registration — How to Navigate the Colombian Ecosystem Successfully

Did you know that the biosimilars market in LATAM could exceed USD 7.6 billion by 2025? (Biosimilars Council, 2022). Colombia is emerging as a key player, thanks to its agile regulatory framework, an active authority such as INVIMA, and policies that promote access to biotechnological medicines.

In this first article, we explore the fundamentals that every company should understand to successfully register a biosimilar in Colombia—from understanding how they differ from other medicines to overcoming technical challenges and avoiding common regulatory pitfalls

WHAT BIOSIMILARS ARE (AND ARE NOT)

Biosimilars are biological medicines that are highly similar to an already approved reference product. While they are not identical copies, they must meet stringent standards of quality, safety, and efficacy as defined by regulatory bodies like INVIMA, the FDA, and EMA.

Some common misconceptions:

• They are not generics: Unlike chemically synthesized drugs, where it is possible to create structurally identical active ingredients regardless of manufacturing processes, biosimilars are developed through complex biotechnological processes and have inherent variability. Therefore, the regulatory pathway to demonstrate equivalence is generally longer and more complex than for generics.
• They are not entirely new medicines: Biosimilars derive from a previously approved biological product, usually referred to as the reference product. While this shortens development timelines, they still undergo rigorous regulatory scrutiny, with a strong focus on quality.
• They are not automatically interchangeable. Clinical interchangeability is not assumed; it must be demonstrated with robust evidence and approved by the health authority on a case-by-case basis.

In recent years, Colombia has made significant regulatory advances. INVIMA has implemented measures to streamline biosimilar evaluations while maintaining high technical standards. This environment is favorable for market entry, but it also demands strong technical preparation.

HOW TO REGISTER BIOSIMILARS IN COLOMBIA

There are currently three regulatory pathways for biological products in Colombia: the full dossier route, the comparability route, and the abbreviated comparability route. The latter two are especially relevant for biosimilars.

The registration process with INVIMA requires companies to technically and documentally demonstrate the similarity to the reference biological product across several areas:

• Quality and manufacturing: Includes physicochemical characterization, biological identity tests, potency and biological activity assessments, purity evaluations, stability studies, quality control processes, and compliance with Good Manufacturing Practices (GMP).
• Clinical safety and efficacy: Demonstrated through comparative non-clinical and/or clinical studies, focusing on pharmacokinetics, pharmacodynamics, toxicology, and immunogenicity.
• Traceability: A robust system must be in place to identify and track the product across the entire distribution chain.
• Regulatory compliance: The dossier must align with INVIMA’s technical guidelines and be consistent with international standards from WHO, EMA, or FDA, when applicable.

Although the process may be shorter than for an innovative biologic, strategic planning from the development stage is crucial to avoid rework and streamline timelines.

COMMON MISTAKES AND REGULATORY CHALLENGES (AND HOW TO AVOID THEM)

Registering a biosimilar in Colombia involves navigating not only technical requirements but also operational and regulatory complexities. Here are some of the most common pitfalls and strategic challenges companies face:

• Poor selection of the reference product: The same reference product must be used throughout the entire comparability exercise, and it must be appropriate to support the marketing authorization request. The biosimilar’s dosage form, strength, and administration route must match those of the reference product.
• Insufficient or poorly designed comparative studies: Often, evidence is not robust enough to demonstrate similarity, or the wrong comparator is chosen, leading to additional requests or outright rejections.
• Lack of knowledge about the Colombian regulatory framework: Applying a strategy based on other jurisdictions without adapting it to the local context can result in delays or even rejection.
• Weak pharmacovigilance planning: Some companies see it as a post-registration requirement, when in fact it should be embedded from the earliest stages.
• Underestimating immunogenicity risks: Without prospective analysis and specific controls, companies risk regulatory rejection and limited clinical acceptance.
• Limited or delayed communication with INVIMA: The absence of a clear technical dialogue with the authority can lead to misunderstandings, unnecessary requirements, and prolonged evaluation timelines.

WHY FREYR MAKES THE DIFFERENCE

At Freyr, we support companies seeking to enter the Colombian biosimilars market with an integrated perspective—technical, strategic, and deeply aligned with INVIMA’s expectations. We know that regulatory success is not only about compliance, but also about foresight, technical clarity, and expert communication.

Here’s how we can help your organization:

✔️ Define a tailored biosimilarity strategy from the outset, aligned with regulatory requirements and INVIMA’s expectations.
✔️ Optimize the dossier content, ensuring that each technical module demonstrates scientific rigor and regulatory consistency.
✔️ Design a robust and contextualized pharmacovigilance system from the early project stages, including key aspects such as immunogenicity.
✔️ Maintain ongoing technical dialogue with INVIMA, enabling clear and timely responses to regulatory feedback.

With our support, you reduce risk and rework, enhance your positioning with the health authority, and maximize your approval chances.

IN SUMMARY…

Success in registering a biosimilar in Colombia requires a well-structured strategy—exactly what Freyr provides—based on a deep understanding of local requirements and technical expertise to anticipate challenges.

🔜 IN OUR NEXT ARTICLE... We’ll dive into INVIMA’s pharmacovigilance and traceability requirements, and how other LATAM countries are adopting similar standards. We’ll also share practical tips for maintaining compliance and protecting market trust.