Brazil’s health regulator Anvisa has barred the compounding of the blockbuster weight-loss injections Ozempic and Wegovy, both based on the active ingredient semaglutide. A resolution published in the Diário Oficial da União on 25 August restricts the import of biotechnologically produced semaglutide for manipulation to the drug’s marketing-authorisation holder—Novo Nordisk—effectively preventing pharmacies from preparing copycat formulations. Anvisa said the move was needed because manufacturing sterile GLP-1 injectables involves “high pharmacotechnical complexity” and poses significant sanitary risks. The agency noted that no synthetic version of semaglutide is registered in Brazil, leaving no legal pathway for compounded alternatives until such approval exists. Brazilian medical societies, including the SBEM and the Brazilian Diabetes Society, had urged tighter oversight, warning that compounded GLP-1 products were not subject to the rigorous quality, purity and bioequivalence tests required of approved medicines. The ban comes amid surging demand for anti-obesity treatments and follows reports of counterfeit or substandard versions entering the market.
Decisão da Anvisa veta Ozempic e Wegovy manipulados no Brasil https://t.co/0c7UQGt88E
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