Brasília – The National Health Surveillance Agency (ANVISA) reports that it has received at least 14 registration requests for medicines containing semaglutide, reflecting strong industry interest following the expiration of the molecule’s patent in March 2026. The agency notes that these applications are at different stages of review and are subject to standard regulatory requirements for quality, safety, and efficacy.

ANVISA emphasizes that none of the products under analysis are classified as generics, given the specific regulatory pathway for biologic products, and approvals will depend on rigorous technical evaluation. The agency also highlights that prioritization measures have been adopted to accelerate the review of high-demand therapies, although timelines remain uncertain and contingent on the submission of complete data by applicants.

Source: Agência Gov