EMS semaglutide medication Yluméc approved by Anvisa

Anvisa has approved the registration of Yluméc, a new semaglutide-based medication developed by the Brazilian pharmaceutical company EMS. The drug is indicated for the treatment of adults with type 2 diabetes mellitus.

Classified as a similar medication (clone) in the regulatory process, Yluméc uses Ozivy, another EMS-developed semaglutide product, as its reference. The approval follows the expiration of the patent for Ozempic in March. The medication will be available in injectable pen formats with concentrations of 1.34 mg/mL, offered in 1.5 mL and 3 mL cartridges to accommodate various weekly dosages.

Production will take place at EMS's peptide factory in Hortolândia, São Paulo. While the registration is official, the commercial launch date and consumer pricing are yet to be determined, as the product must still undergo price definition by the Drug Market Regulation Chamber (CMED).