Dr Reddy's Laboratories receives ANVISA approval for generic semaglutide injection in Brazil

Dr Reddy’s Laboratories announced on Thursday that it received marketing authorisation for its generic semaglutide injection from Brazil’s National Health Surveillance Agency (ANVISA).

According to the company’s statement, the product will be available as a pre-filled, multi-dose injectable pen in two presentations, 2 mg/1.5 mL and 4 md/3 mL, for once-weekly dosing.

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“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,” MV Ramana, Chief Executive Officer, Global Generics, Dr. Reddy’s Laboratories, said.

The company said its generic drug is used in the treatment of insufficiently controlled type 2 diabetes mellitus in adults, alongside 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 mellitus, according to its presser.

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Highlighting the generic injection’s market potential, the statement said Brazil has significant treatment demand, estimated at approximately $ 244.6 million, as 16.6 million adults aged 20–79 are living with diabetes and ranks sixth globally in terms of the number of adults living with diabetes.