The National Health Surveillance Agency (Anvisa) of Brazil announced it will reveal its decision next week concerning the registration requests for national versions of semaglutide-based pens, a key component of the diabetes medication Ozempic. The pharmaceutical companies EMS and Ávita Care have submitted their applications, which are currently under review. The urgency arises as the patent for semaglutide, developed by Danish pharmaceutical company Novo Nordisk, expires on March 20. This expiration means that other pharmaceutical companies will soon be able to manufacture and sell medications based on semaglutide in Brazil, as long as they receive the necessary regulatory approvals.

Last year, the Brazilian Ministry of Health urged Anvisa to prioritize the assessment of local pen versions, leading to significant developments anticipated in the coming weeks. However, while the approvals are expected soon, there is no guarantee that Anvisa will grant immediate approval. The agency has the authority to request additional information from the companies before making its final decision, which could potentially delay the availability of these critical medications in the market.

The decision expected from Anvisa has broader implications for diabetes treatment accessibility in Brazil. As more companies gain the right to manufacture medications containing semaglutide, it is likely to impact the pricing and availability of these essential drugs. This could lead to increased competition that ultimately benefits patients requiring diabetes care, highlighting the significance of regulatory decisions at local health agencies.