Dr. Reddy's Wins Brazil Regulatory Nod for Generic Semaglutide, Partners with Ache for Launch
New Delhi: Hyderabad-based Dr. Reddy's Laboratories has received marketing authorization from Brazil's National Health Surveillance Agency (ANVISA) for its generic semaglutide injection for the treatment of adults with type 2 diabetes, strengthening the company's global semaglutide expansion strategy.
The approval covers semaglutide injection for adults with insufficiently controlled type 2 diabetes mellitus, as an adjunct to diet and exercise. The treatment can be used as monotherapy when metformin is inappropriate 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, designed for once-weekly administration.
Dr. Reddy’s plans to launch the generic semaglutide injection in Brazil in partnership with pharmaceutical company Aché.
Brazil represents a significant opportunity for the company, with approximately 16.6 million adults aged 20–79 living with diabetes, making it the sixth-largest country globally by adult diabetes population.
The semaglutide market for diabetes treatment in Brazil is estimated at approximately $244.6 million, highlighting the potential demand for affordable treatment options.
Commenting on the approval, MV Ramana, Chief Executive Officer, Global Generics, Dr. Reddy’s Laboratories, said the company's focus with semaglutide is to expand access to the treatment across markets with significant patient needs.
He noted that Brazil, given its substantial diabetes burden, is an important market in the company's expansion strategy. The latest approval builds on Dr. Reddy’s broader semaglutide strategy and brings it closer to making the treatment available to more patients.
The Brazilian authorization marks another step in Dr. Reddy’s efforts to expand its global presence in the semaglutide market and strengthen access to diabetes treatments.
Dr. Reddy’s Laboratories Limited is a global pharmaceutical company headquartered in Hyderabad, India. Established in 1984, the company focuses on providing access to affordable and innovative medicines.
Its portfolio includes active pharmaceutical ingredients (APIs), generics, branded generics, biosimilars and over-the-counter (OTC) products.
The company's key therapeutic areas include gastrointestinal, cardiovascular, diabetology, oncology, pain management and dermatology. Its major markets include the US, India, Russia and CIS countries, China, Brazil and Europe.
Driven by its purpose, 'Good Health Can't Wait', Dr. Reddy’s continues to invest in scientific research, future businesses, sustainability and improved access to affordable healthcare.
