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This study develops a proposed national guide for evaluating applications for sanitary registration of biosimilar medicines in Panama, harmonized with international standards.
Biosimilar medicines represent a safe, effective, and cost-effective therapeutic alternative to reference biological products. However, their approval requires robust regulatory frameworks that guarantee quality, safety, and efficacy. In Panama, Law 419 (2024) and Executive Decree No. 27 (2024) establish the legal foundations, but technical and procedural gaps persist.
A qualitative, exploratory, observational, and documentary study was conducted. International guidelines issued by the European Medicines Agency (EMA), the United States Food and Drug Administration (FDA), the World Health Organization (WHO), and the regional regulations of ANVISA (Brazil) and ANMAT (Argentina) were reviewed. The comparative analysis also included provisions established in Panama, including Law 419 of 2024 and Executive Decree No. 27 of 2024. The comparative analysis identified similarities, divergences, and gaps in the evaluation processes.
International agencies agree on a stepwise approach based on the totality of evidence, prioritizing analytical comparability, sensitive PK/PD studies, and immunogenicity. In Panama, limitations were detected regarding guidelines on interchangeability, specific pharmacovigilance, traceability, and abbreviated reliance procedures.
The implementation of a national technical guide aligned with international standards will strengthen the DNFD's capacity, optimize regulatory evaluation, and ensure safe access to biosimilar medicines, promoting a more equitable and sustainable health system.
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