Brazil's Anvisa approves five new semaglutide injection pens
Brazil's National Health Surveillance Agency (Anvisa) registered five semaglutide injectable pens—Owozy, Seemasun, Zempneo, Semavy and Orsema—for adults with type‑2 diabetes whose condition is not adequately controlled. The approvals, published in the Diário Oficial da União under resolutions 2.941/2026 and 2.942/2026, represent the largest batch of GLP‑1 agonist registrations to date. The products were approved by comparison with the reference biologic Ozempic and are assigned to Ávita Care, Sun Farmacêutica, Brainfarma, Cosmed and Ranbaxy.
The move expands the domestic market for GLP‑1 medicines, which generated roughly R$ 13.3 billion in Brazil over the past year. Analysts note that the new brands will increase competition but, because they are not classified as generics, automatic pharmacy substitution does not apply. Production will occur abroad (China, India) and pricing will be set by the Câmara de Regulação do Mercado de Medicamentos. Anvisa also warned about illegal sales of the experimental drug Retatrutida, which remains unapproved worldwide.
Entities: Agência Nacional de Vigilância Sanitária (Anvisa) · Brazil · Hypera · Owozy · Ozempic · Seemasun · Semaglutide
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- [● 3 SOURCES] Anvisa approved registration of five semaglutide injection pens for adult type‑2 diabetes patients in Brazil. (new)