News ArticleDr. Reddy's Secures Marketing Authorization for Generic Semaglutide Injection in Brazil for Type 2 Diabetes Treatment
Brazil's ANVISA approves twice-weekly injectable treatment expanding Dr. Reddy's portfolio in Latin America's key diabetes market
Dr. Reddy's Laboratories Ltd. has received marketing approval from Brazil's ANVISA for its generic semaglutide injection to treat adults with type 2 diabetes, expanding the company's presence in the Latin American diabetes treatment market.
Dr. Reddy's Laboratories Ltd.
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Dr. Reddy's Laboratories announced it has received marketing authorization from Brazil's National Health Surveillance Agency (ANVISA) for its generic semaglutide injection, designed to treat adults with insufficiently controlled type 2 diabetes mellitus as an adjunct to diet and exercise.
The approved semaglutide injection will be available in pre-filled, multi-dose pens with dosages of 2 mg/1.5 mL and 4 mg/3 mL, for once-weekly use.
This approval marks Dr. Reddy's expansion into Brazil, a country with 16.6 million adults living with diabetes, ranking sixth worldwide in diabetes prevalence.
Brazil's semaglutide market for diabetes treatment is estimated at approximately USD 244.6 million, highlighting the significant demand for effective diabetes therapies.
Dr. Reddy’s plans to launch the generic semaglutide in Brazil in partnership with the local pharmaceutical company Aché.
Highlights
- Marketing authorization granted by Brazil's ANVISA for generic semaglutide injection.
- Treatment targets adults with type 2 diabetes with insufficient glycemic control as adjunct therapy to diet and exercise.
- Product supplied as pre-filled injectable pens in two dosage presentations: 2 mg/1.5 mL and 4 mg/3 mL.
- Brazil has 16.6 million adults aged 20-79 living with diabetes, ranking sixth globally by prevalence.
- Estimated semaglutide market size in Brazil is approximately USD 244.6 million.
- Dr. Reddy's to launch semaglutide in Brazil in collaboration with Aché.
Key Data Snapshot
What happened
- Dr. Reddy's Laboratories received marketing authorization from Brazil’s ANVISA for its generic semaglutide injection to treat type 2 diabetes mellitus.
- The approval allows marketing use as an adjunct to diet and exercise, either as monotherapy or in combination with other diabetes medicines.
Key details
- The product will be provided in pre-filled, multi-dose injectable pens in two dosage forms: 2 mg/1.5 mL and 4 mg/3 mL, intended for once-weekly dosing.
- Dr. Reddy’s plans to launch this product in Brazil in partnership with Aché, a local pharmaceutical company.
Strategic context
- Brazil is one of the key markets in Latin America with 16.6 million adults living with diabetes, ranking sixth globally by diabetes prevalence.
- The Brazilian market for semaglutide diabetes treatment is estimated at approximately USD 244.6 million.
- This authorization supports Dr. Reddy’s expansion strategy to increase access to semaglutide treatment in significant diabetes markets.
Regulatory and governance context
- Marketing authorization was granted by the National Health Surveillance Agency (ANVISA) of Brazil, the regulatory body responsible for market approvals. ]}],
- disclosures":{"regulatory_references":["SEBI (Listing Obligations and Disclosure Requirements) Regulations, 2015","ANVISA marketing authorization"],"related_party":null,"promoter_interest":null,"forward_looking_note":"The press release includes forward-looking statements about plans and expectations
Highlights
- Marketing authorization granted by Brazil's ANVISA for generic semaglutide injection.
- Treatment targets adults with type 2 diabetes with insufficient glycemic control as adjunct therapy to diet and exercise.
- Product supplied as pre-filled injectable pens in two dosage presentations: 2 mg/1.5 mL and 4 mg/3 mL.
- Brazil has 16.6 million adults aged 20-79 living with diabetes, ranking sixth globally by prevalence.
- Estimated semaglutide market size in Brazil is approximately USD 244.6 million.
- Dr. Reddy's to launch semaglutide in Brazil in collaboration with Aché.
Disclosures
- SEBI (Listing Obligations and Disclosure Requirements) Regulations, 2015
- ANVISA marketing authorization
Source Information
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