Anvisa Approves Second Generic Semaglutide Medication in Brazil

Brazil's health regulatory agency, Anvisa, approved the country's second generic version of semaglutide. The registration, granted to the pharmaceutical company Germed, was published in the Official Gazette of the Union on Monday, September 24. This follows the approval of a first generic version from EMS on September 17. The new Germed medication will be available in four presentations of injectable solutions with a concentration of 1.34 mg/mL for subcutaneous administration, including 1.5 mL and 3 mL cartridges. These products have a registration validity of 24 months. Semaglutide is the active ingredient in medications such as Ozempic and Wegovy, and it works by mimicking the GLP-1 hormone to regulate glucose and increase satiety. Under Brazilian law, generic drugs must be priced at least 35 percent lower than the reference medication. Anvisa Director President Leandro Safatle stated that the agency could approve up to eight more weight loss pens by the end of 2026, noting that the government is monitoring these registrations with the goal of potentially incorporating them into the Unified Health System (SUS). The approval comes as the market for semaglutide expands following the expiration of the patent previously held by Novo Nordisk on March 20. The current national market includes 21 registered medications, comprising imported reference products, biosimilars, and synthetic options.