Biocon Limited announced on February 24, 2026, that it has received U.S. FDA approval for its complex formulation, Liraglutide Injection, marketed as gSaxenda®. This approval covers the 18 mg/3 mL (6 mg/mL) single-patient-use prefilled pens for chronic weight management. Biocon commits to commercializing this high-quality, affordable treatment option rapidly in the U.S. market, which represents a significant growth area for GLP-1 therapies.
Biocon Receives Key U.S. FDA Approval
Biocon Limited, an innovation-led global biopharmaceuticals company headquartered in Bengaluru, confirmed on February 24, 2026, that it secured approval from the U.S. FDA for its complex formulation: Liraglutide Injection, 18 mg/3 mL (6 mg/mL) single-patient-use prefilled pens, branded as gSaxenda®.
Liraglutide is classified as a drug-device combination formulation utilized in treating chronic weight management. Its indication is specifically as an adjunct therapy alongside a reduced-calorie diet and increased physical activity.
Strategic Milestone and Market Opportunity
Siddharth Mittal, Chief Executive Officer and Managing Director of Biocon Ltd, highlighted this approval as a defining milestone, validating the company’s scientific depth and vertically integrated platform. Mittal stated that GLP-1 therapies are a significant growth driver, with the U.S. being a crucial market for Biocon’s strategy.
The company emphasized its commitment to ensuring patients in the U.S. gain access to a high-quality, affordable treatment option.
The announcement noted that GLP-1 receptor agonists are one of the fastest-growing therapeutic classes globally. Data cited from IQVIA MAT December 2025 indicated that the total addressable market opportunity for GLP-1 in weight loss within the U.S. was valued at US $127 million.
About Liraglutide and GLP-1 Therapies
Glucagon-like peptide-1 (GLP-1) Overview
GLP-1 medications function by lowering blood sugar levels and promoting weight loss. These physiological hormones act on GLP-1 receptors, augmenting insulin secretion, inhibiting glucagon secretion, slowing gastric emptying, and ultimately limiting weight gain.
Liraglutide Background
Liraglutide is a synthetic analog of the GLP-1 peptide, administered via a once-daily injection. It received approval for medical use in the European Union in 2009 and in the United States in 2010. The U.S. FDA initially approved Liraglutide in 2014 for adults who are obese or overweight with at least one weight-related condition. Furthermore, in 2019, the U.S. FDA approved its use for treating children ten years or older with type 2 diabetes, marking it the first non-insulin drug approval for that indication since metformin in 2000.
Investor and Media Contacts
The company provided contact information for media relations and investor relations:
- Media Relations: Calvin Printer, +91 7032969537, [email protected]
- Investor Relations: Prashant Nair, +91 9820095476, [email protected]
Source: BSE
