Dr Reddy’s Laboratories has received marketing authorisation from Brazil’s National Health Surveillance Agency (ANVISA) for its generic semaglutide injection for the treatment of adults with inadequately controlled type 2 diabetes mellitus.

The approval covers the use of semaglutide as an adjunct to diet and exercise, either as a monotherapy when metformin is unsuitable due to intolerance or contraindications, or in combination with other diabetes medications.

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, intended for once-weekly administration.

Brazil has approximately 16.6 million adults aged 20–79 living with diabetes, ranking sixth globally in terms of the number of adults affected by the condition. The country's semaglutide market for diabetes treatment is estimated at approximately USD 244.6 million, reflecting the significant demand for treatment options.

Commenting on the approval, MV Ramana, Chief Executive Officer, Global Generics, Dr Reddy’s Laboratories, said that the company aims to expand access to semaglutide across markets with significant patient needs. He added that the Brazilian approval represents another step in the company's broader semaglutide strategy.

Dr Reddy’s plans to launch the product in Brazil in partnership with Aché.