Brazil combats illegal weight-loss drug market as Anvisa fast-tracks generics

Brazil is facing a rise in the clandestine market for injectable weight-loss medications, particularly in the state of Pará. Authorities have reported a surge in the seizure of counterfeit, smuggled, or unregulated substances, including semaglutide, tirzepatide, and liraglutide. Data from the Federal Revenue and Federal Police indicate a significant increase in seizures of weight-loss pens and vials originating from Paraguay, with over 115,000 units seized in 2026.

Recent enforcement actions include the arrest of individuals at airports in Santarém and Rio de Janeiro for transporting illegal weight-loss pens and anabolic steroids. Additionally, the Federal Highway Police intercepted tirzepatide shipments without proper documentation.

In response to the growing demand and the expiration of patents, Brazil's National Health Surveillance Agency (Anvisa) has introduced a new regulation, Normative Instruction 469. This rule aims to accelerate the registration process for generic and similar versions of semaglutide-based medications that have exceeded legal analysis deadlines. This regulatory shift follows the recent approval of synthetic versions of the active ingredient, such as EMS’s Ozivy, and aims to increase market competition through optimized quality analysis for injectable solutions.