Dr. Reddy’s Laboratories Ltd. has secured marketing authorization from Brazil’s health regulator, ANVISA, for its generic semaglutide injection. The once-weekly treatment is approved for adults with inadequately controlled type 2 diabetes as a supplement to diet and exercise. It can be prescribed as a standalone monotherapy for patients unable to take metformin due to intolerance or contraindications, or used in combination with other diabetes medications. The generic drug will be delivered via pre-filled, multi-dose injectable pens available in two strengths: 2 mg/1.5 mL and 4 mg/3 mL.

Brazil has 16.6 million adults aged 20–79 living with diabetes and ranks sixth globally in terms of the number of adults living with diabetes. Reflecting the significant treatment need in the country, the semaglutide market for diabetes is estimated at approximately US$ 244.6 million.

Commenting on the approval, MV Ramana, Chief Executive Officer, Global Generics, Dr. Reddy’s Laboratories, said, “Our focus with semaglutide is to expand access to this treatment option across markets where the patient need is significant. Brazil, with its substantial burden of diabetes, is an important part of that journey. This approval builds on our broader semaglutide strategy and brings us another step closer to making semaglutide available to more patients. We plan to launch semaglutide in Brazil with Aché.”