Dr. Reddy’s Laboratories announced that Brazil’s National Health Surveillance Agency (ANVISA) has granted marketing authorization for its generic semaglutide injection. This approval is for the treatment of adults with insufficiently controlled type 2 diabetes mellitus and is positioned as an adjunct to diet and exercise. The product will be available in a pre-filled, multi-dose injectable pen in two presentations, for once-weekly dosing. This marks an expansion into a key market in Latin America.
Dr. Reddy’s Secures Brazil Approval for Diabetes Treatment
Dr. Reddy’s Laboratories Ltd. today announced a significant development in its global diabetes portfolio. The company’s generic semaglutide injection has received marketing authorization from Brazil’s National Health Surveillance Agency (ANVISA).
Therapeutic Application and Product Details
This authorization is specifically for the treatment of adults diagnosed with insufficiently controlled type 2 diabetes mellitus. The semaglutide injection is intended to be used as an adjunct to diet and exercise. It can be administered either as a monotherapy, particularly when metformin is deemed inappropriate due to intolerance or contraindications, or in combination with other medicinal products for diabetes management.
The product will be available in Brazil as a pre-filled, multi-dose injectable pen. It will be offered in two presentations: 2 mg/1.5 mL and 4 mg/3 mL, designed for convenient once-weekly dosing.
Market Significance and Strategy
Brazil represents a key market within Latin America, with a substantial patient population living with diabetes. The country has approximately 16.6 million adults aged 20-79 living with diabetes and ranks sixth globally in this regard. The semaglutide market for diabetes in Brazil is estimated to be worth approximately USD 244.6 million.
MV Ramana, Chief Executive Officer, Global Generics at Dr. Reddy’s Laboratories, stated, “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.” The company plans to launch semaglutide in Brazil in partnership with Aché.
Company Overview
Dr. Reddy’s Laboratories Ltd., headquartered in Hyderabad, India, is a global pharmaceutical company. Established in 1984, it is committed to providing access to affordable and innovative medicines. The company’s purpose is ‘Good Health Can’t Wait’. Its product and service portfolio includes APIs, generics, branded generics, biosimilars, and OTC products. Key therapeutic areas of focus include gastrointestinal, cardiovascular, diabetology, oncology, pain management, and dermatology. Dr. Reddy’s operates in major markets such as the USA, India, Russia & CIS countries, China, Brazil, and Europe. The company has a history of deep science and innovation and is an early adopter of sustainability and ESG actions, having released its first Sustainability Report in 2004.
Source: BSE
