Anvisa Approves Second Generic Semaglutide in Brazil

Overview

• Anvisa published the Germed registration in the Diário Oficial da União on Monday, marking the agency's second approval of a national generic semaglutide product this month.
• The approved Germed product is indicated for type 2 diabetes, supplied as a 1.34 mg/mL subcutaneous solution in four cartridge and pen-kit presentations and carries a 24-month registration term.
• Brazil now has two domestic semaglutide generics after EMS received the first approval on Aug. 17, allowing national manufacturers to compete with Novo Nordisk's branded products.
• By law generics must be sold at least 35% below the reference product, so the new entries are expected to lower retail prices from current listings that start near R$460.
• Anvisa is still reviewing additional semaglutide applications, so further market entry could expand supply, reduce out-of-pocket costs for patients, and increase pricing pressure on the incumbent manufacturer.