Challenges and progress in the registration of biosimilars in Latin America

Biosimilars/General | Posted 25/06/2024 post-comment0 Post your comment

Biosimilar medicines offer an effective and economical alternative to biotechnological medicines, with a rapidly expanding global market. However, Latin America still faces several significant challenges. The obstacles and advancements experienced in recent years are detailed below.

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– Regulatory frameworks (inconsistent regulations): the lack of specific and harmonized regulations for the registration of biosimilars in some countries complicates the approval process. Establishing clear and consistent standards is crucial to ensure the safety and effectiveness of these medicines.
– Investment in R&D (funding deficiencies): limited investment in research and a scarcity of regional or global developments hinder progress.
– Training and expertise (skill gaps): the lack of experts and technical personnel in biosimilars prevents overcoming regulatory hurdles and promoting the development of innovative products.
– Technical complexity (advanced analysis requirements): biosimilars are complex molecules, and their characterization requires advanced analytical techniques. This may pose certain challenges in terms of demonstrating similarity to the reference product and ensuring its quality, safety, and efficacy.
– Perception and trust (variable confidence): healthcare professionals and patients often have varying perceptions regarding the equivalence of biosimilars and reference products. This lack of trust can impede the adoption and usage of biosimilars, even when available in the market.
– Access and costs (economic barriers): although biosimilars are marketed as cheaper alternatives to reference products, costs can still be significant. 

Progress and Developments
– Regulatory harmonization (collaborative efforts): significant efforts have been made toward harmonizing biosimilar regulations in Latin America. Collaboration between Latin American regulatory agencies and the exchange of best practices are contributing to this progress.
– Education and awareness (awareness campaigns): initiatives aimed at educating healthcare professionals and patients about biosimilars are ongoing. These campaigns emphasize the safety, efficacy, and equivalence of biosimilars with reference products, helping to build confidence in these medications and encourage their appropriate use.

Noteworthy Initiatives
1. Brazil’s Strategic Plan
ANVISA’s 2024-2027 Agenda
Brazil's National Health Surveillance Agency (ANVISA) has developed a strategic plan for 2024-2027, aiming for the World Health Organization (WHO) recognition.  Priorities include adopting Identification of Medicinal Products (IDMP) standards and the modernizing data platforms to enhance regulatory processes.

2. Mexico's Regulatory Improvements
COFEPRIS's 2024 Agenda
Mexico's Federal Commission for the Protection against Sanitary Risks (COFEPRIS) has outlined its 2024 agenda, focusing on improving regulatory certainty, promoting digitalization, enhancing manufacturing capabilities to meet international standards, and launching a biosimilars unit and pharmaceutical development committee [1].

Pablo Quiroga, Executive Director of Health Promotion at COFEPRIS, highlights the interest in biosimilars in Mexico due to regulatory advances and strategic opportunities. However, he faces challenges in regulation and awareness that must be addressed to ensure market success. The risk of not addressing these challenges could affect production and competition in the biosimilar sector.

While significant challenges remain, Latin America is making noteworthy progress in the biosimilar sector. Efforts to harmonize regulations, educate stakeholders, and modernize regulatory frameworks are pivotal steps forward. With continued investment in R&D, training, and awareness, the region can overcome barriers and fully realize the benefits of biosimilar medicines.

The regulatory situation of biosimilars in Latin America varies widely between different countries, despite the fact that the region is moving towards the consolidation of defined and standardized regulatory pathways for these products [2]. 

Related articles
COFEPRIS promotes regulatory cooperation in the Americas

The effects of regulation on innovation in Mexican pharmaceutical industry

The new section of the ‘Latin American Forum’ on GaBI has been launched. The objective of this new section is to provide you with all the latest news and updates on developments of generic and biosimilar medicines in Latin America in Spanish.

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1. GaBI Online - Generics and Biosimilars Initiative. Strategic plans of ANVISA and COFEPRIS to advance health regulation []. Mol, Belgium: Pro Pharma Communications International; [cited 2024 Jun 25]. Available from:
2. GaBI Online - Generics and Biosimilars Initiative. Regulatory landscape for biosimilars in Latin America []. Mol, Belgium: Pro Pharma Communications International; [cited 2024 Jun 25]. Available from:

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