Overview
- Anvisa published the registration for Yluméc on Monday, August 31, 2026, formalizing the decision signed by the agency’s medicines GM on August 28 and printed in the Diário Oficial da União.
- The agency classified Yluméc as a 'similar — registro de produto — clone' linked to EMS’s earlier product Ozivy, which means it is not a generic copy of Novo Nordisk’s drugs.
- Yluméc is registered as a 1.34 mg/mL subcutaneous semaglutide solution in four cartridge-and-pen presentations, carries a 24-month shelf life, and has a registration valid through August 2036.
- The drug has no sale date because the Câmara de Regulação do Mercado de Medicamentos (CMED) must set the maximum price before commercialization, and Yluméc is not automatically subject to the 35% minimum price cut that applies to generics.
- The registration comes after semaglutide’s patent expired in March 2026 and follows a rapid rise in new brands and generics, a shift that could raise supply and choice for patients but will leave real-world access tied to CMED decisions and manufacturers’ launch plans.