Dr. Reddy’s Laboratories announced that Brazil’s National Health Surveillance Agency (ANVISA) has granted marketing authorisation for generic semaglutide injection for the treatment of adults with insufficiently controlled type 2 diabetes mellitus, as an adjunct to diet and exercise, either as monotherapy when metformin is considered inappropriate due to intolerance or contraindications, or in addition to other medicinal products for the treatment of diabetes.
The product will be available as a pre-filled, multi-dose injectable pen in two presentations, 2 mg/1.5 mL and 4 mg/3 mL, for once-weekly dosing.
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 USD 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.”