[REVISION HISTORY]

Semaglutide regulatory approvals and pricing in Brazil

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What changed

2026-08-25 22:13 UTC → 2026-08-31 19:59 UTC · added ~~removed~~

Brazil’s National Health Surveillance Agency (Anvisa) has expanded the domestic market for semaglutide, a medication used to treat type 2 diabetes and weight loss. Initially, Anvisa registered five new semaglutide injectable pens—Owozy, Seemasun, Zempneo, Semavy, and Orsema—for adults with inadequately controlled type 2 diabetes. These products were approved via comparison with the reference biologic Ozempic and are assigned to various companies including Ávita Care and Sun Farmacêutica. Because these were not classified as generics, automatic pharmacy substitution does not apply. Following these registrations, Anvisa approved the country’s first generic and similar versions of the medication. EMS received registration for a generic version named Ozivy, which utilizes a synthetic version of the active ingredient and includes four different injectable pen presentations of 1.34 mg/mL in various pen and kit configurations. Additionally, Germed received approval for a similar version of the drug to be sold under the name Semaclique. Following the expiration of the substance's patent in March 2026, the market has seen further regulatory milestones. Anvisa recently approved the registration of a second generic version of semaglutide, granted to Germed Farmacêutica. This follows the EMS generic approval by just one week. The new Germed generic will be available in four injectable presentations and is expected to be priced at least 35% lower than reference products like Ozempic and Wegovy. In response to increased competition, Eurofarma has announced price reductions of up to 39% for its Poviztra product for patients enrolled in its EuroCuida support program. Further expanding the market, Anvisa approved Yluméc, a new semaglutide-based medication from EMS. Classified as a ‘clone’ similar to the EMS product Ozivy, Yluméc is indicated for adults with type 2 diabetes and will be available in weekly subcutaneous injection pens with 1.5 mL and 3 mL cartridge options.

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