The Central American Integration System (SICA)—a regional bloc comprising Central American nations and the Dominican Republic—took a significant step toward creating a joint mechanism for evaluating biosimilar and biotechnological medicines with a technical workshop held in Santo Domingo from 1–3 June 2026. The event brought together regulatory authorities from across the region to advance a common evaluation guide—a foundational step toward expanding patient access to these cost-saving therapies.
A regionally coordinated push on biosimilars
The Santo Domingo workshop, formally titled the 'Regional Workshop for the Exchange of Experiences on the Use of the Technical Evaluation Guide for Biotechnological and Biosimilar Medicines', follows a similar session held in Antigua, Guatemala, in January 2026. Organized under the pro tempore presidency of the Council of Health Ministers of Central America and the Dominican Republic (COMISCA), the initiative aims to consolidate a joint evaluation model that allows countries to share specialized knowledge and avoid duplicating regulatory efforts
During the workshop, specialists are exchanging experiences on the application of the regional guide for evaluating biotechnological and biosimilar medicines. The activity has the support of experts from the Spanish Agency for Medicines and Health Products (AEMPS), the Spanish Agency for International Development Cooperation (AECID), and the Spain-SICA Fund.
Dominican Health Minister Dr Víctor Atallah called biosimilars a 'key tool' for expanding access to costly biological treatments—despite persistent misconceptions—and stressed that 'innovation without access only generates more inequality'.
The longer-term goal is the establishment of the Central American Health Regulatory Agency (ACRS), a SICA-wide body that would eventually conduct binding evaluations of biosimilars and other biological products.
Learning from Europe’s biosimilar blueprint
SICA is closely studying the European Medicines Agency (EMA), which established the world's first dedicated biosimilar framework in 2005. Over two decades, the EMA has reviewed 180 biosimilars and approved more than 160—the highest number globally. All biosimilars in the EU undergo a mandatory centralized procedure, ensuring uniform scientific assessment across all Member States.
Recently, the EMA proposed streamlining approval requirements, potentially reducing the need for extensive comparative clinical trials, reflecting advances in analytical methods [1].
A comparative perspective
The regulatory situation for biosimilars in Latin America varies widely between countries. SICA's joint evaluation mechanism is key to strengthening regional health regulation and improving access to innovative treatments for complex diseases.
While SICA draws clear inspiration from the EMA's biosimilar pathway, the two efforts operate at vastly different stages. The EMA's framework is mature, legally binding, and backed by substantial institutional capacity. SICA's initiative, by contrast, remains formative—built on voluntary technical cooperation and gradual harmonization of national guidelines. The proposed ACRS would be a major institutional leap, but the region must navigate challenges Europe has already overcome: building mutual trust between regulators, securing sustainable funding, and developing specialized expertise.
The involvement of Spain's AEMPS signals that SICA is adapting European experience to its own context of smaller economies and less integrated systems. What makes this effort particularly timely is the growing global reliance on biosimilars to contain healthcare costs while expanding treatment coverage. For Central America, a joint regulatory framework for biosimilars is a public health necessity to ensure that innovative biologic therapies do not become yet another source of regional inequality.
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Reference
1. GaBI Online - Generics and Biosimilars Initiative. EMA adopts landmark reflection paper on tailored clinical approach for biosimilars [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2026 Jul 21]. Available from: www.gabionline.net/guidelines/ema-adopts-landmark-reflection-paper-on-tailored-clinical-approach-for-biosimilars
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