Anvisa Approves Yluméc Semaglutide Medication for Type 2 Diabetes

Brazil's health regulatory agency, Anvisa, has approved the registration of Yluméc, a new semaglutide based medication developed by the Brazilian pharmaceutical company EMS for the treatment of type 2 diabetes. The approval was published on Monday, September 31, in the Official Gazette of the Union. Yluméc is registered as a similar medication under the clone modality, using Ozivy, another EMS product, as its reference. This regulatory category allows a drug to be registered based on a previously approved product by utilizing existing technical and regulatory information.

The medication will be available in applicator pens with a semaglutide concentration of 1.34 mg/ml. It will be offered in 1.5 ml volumes, providing four applications of 0.25 mg or 0.5 mg, and 3 ml volumes, providing four applications of 1 mg or 2 mg. The medication is for weekly use. Despite the registration, Yluméc is not yet available in pharmacies. Its commercialization depends on further regulatory steps, including price definition by the Chamber for Drug Market Regulation (CMED).

This approval follows a broader opening of the Brazilian market for semaglutide after the patent held by Novo Nordisk expired on March 20. EMS now has three registered semaglutide products: Ozivy, a generic version, and Yluméc. Other companies have also received approvals recently, including Germed, which registered both a similar medication called Semaclique and a generic version. In July, Anvisa approved five other synthetic semaglutide pens: Owozy, Seemasun, Zempneo, Semavy, and Orsema.