Anvisa approves new semaglutide injectables and Brazil's first generic

Brazil's National Health Surveillance Agency (Anvisa) has approved new injectable medications based on semaglutide for the treatment of type 2 diabetes in adults. These approvals include the country's first official generic semaglutide, registered by EMS, and a similar medication named Semaclique, registered by Germed.

The new products are GLP-1 receptor agonists designed to be used alongside diet and exercise. They are administered weekly via pre-filled pens and must be stored in refrigeration. The entry of generic and similar versions is expected to increase market competition and potentially lower costs for patients, following the expiration of patents for reference drugs like Ozempic.

In the commercial sector, EMS's Ozivy—the first domestically manufactured semaglutide pen in Brazil—reported significant growth, selling 200,000 units in July. This performance helped semaglutide regain market share dominance over tirzepatide in the Brazilian GLP-1 category. Medical experts emphasize that while increased access is beneficial, these medications must be used under strict medical supervision to avoid side effects such as nausea, hypoglycemia, and pancreatitis.