Brazil Approves Five New GLP-1 Diabetes Drugs Following Ozempic Patent Expiration

Brazil's health regulator Anvisa approves five new synthetic semaglutide drugs—Owozy, Seemasun, Zempneo, Semavy, and Orsema—for diabetes and obesity treatment on July 29, 2026. The approvals follow the March 2026 expiration of the Ozempic patent and an accelerated regulatory review initiative to clear backlogs. The new injectables are cleared for adults intolerant to metformin based on clinical comparisons to Ozempic, targeting a rapidly growing domestic weight-loss market.

Anvisa semaglutide drug approvals

• ▪Brazil's health regulator Anvisa approved five new injectable GLP-1 drugs—Owozy, Seemasun, Zempneo, Semavy, and Orsema—for diabetes and obesity treatment on July 29, 2026.
• ▪Brazil has experienced a massive surge in weight-loss pen penetration, outperforming the Latin American regional market average.
• ▪The five newly authorized medications in Brazil use synthetically obtained semaglutide as their active ingredient.

Ozempic patent expiration Brazil

• ▪Anvisa approved the first synthetic semaglutide pen, EMS's drug Ozivy, in May 2026 following the Ozempic patent expiration.
• ▪The patent for the diabetes drug Ozempic expired in Brazil in March 2026.

Accelerated regulatory review initiative

• ▪Anvisa launched an accelerated initiative to clear registration backlogs for semaglutide and liraglutide treatments.
• ▪Anvisa completed reviews for 11 of 24 candidate therapies, resulting in six total approvals after clinical trials, document reviews, and factory inspections.

Clinical comparison authorization pathway

• ▪The five newly approved injectables are authorized based on clinical comparisons to the diabetes drug Ozempic.
• ▪The newly approved medications are cleared alongside diet and exercise for adult patients who cannot tolerate metformin.

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