[REVISION HISTORY]

Semaglutide regulatory approvals and pricing in Brazil

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What changed

2026-08-24 15:29 UTC → 2026-08-25 22:13 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. The approval of these options is expected to increase market competition and potentially lower costs for patients, as Brazilian law requires generic drugs to be priced at least 35% lower than their reference counterparts. While regulatory approvals are complete, specific launch dates and final pricing for these new products have not yet been announced. Medical specialists have noted that while these medications are effective for obesity and diabetes, they must be used alongside diet and exercise. Experts have also warned against common errors such as self-adjusting dosages or ignoring severe digestive symptoms like intense abdominal pain or persistent vomiting. Following the expiration of the substance's patent in March 2026, the market has seen ~~active price adjustments and~~ further regulatory milestones. ~~Eurofarma, which markets Poviztra through~~ Anvisa recently approved the registration of a ~~partnership with Novo Nordisk,~~ 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 ~~semaglutide-based medication used~~ Poviztra product for ~~obesity and cardiovascular risk reduction.~~ patients enrolled in its EuroCuida support program.

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