Biocon gets US FDA nod for chronic weight management drug Liraglutide

Biocon said that it has received approval from the United States Food and Drug Administration (U.S. FDA) for its complex formulation Liraglutide Injection.

Liraglutide is a drug-device combination formulation used in the treatment of chronic weight management, indicated as an adjunct to a reduced-calorie diet and increased physical activity.

GLP-1 receptor agonists have emerged as one of the fastest growing therapeutic classes globally, driven by the rising prevalence of obesity and metabolic disorders, strong clinical outcomes, and increasing physician adoption.

According to IQVIA MAT December 2025 the total addressable market opportunity for GLP-1 in weight loss in the U.S. was US $127 million.

 

Siddharth Mittal, chief executive officer and managing director, Biocon, said: This timely approval of gSaxenda in the United States marks a defining milestone for Biocon, validating our scientific depth, our vertically integrated development and manufacturing platform, and our ability to bring complex drug products to markets around the world.

GLP-1 therapies represent a significant growth driver for the company, with the U.S. being an important market in this strategy.

Biocon is a global biopharma company dedicated to improving affordable access to therapies for chronic conditions such as diabetes, cancer, and autoimmune diseases.

The company's consolidated net profit surged to Rs 143.80 crore in the quarter ended December 2025 as against Rs 25.10 crore during the previous quarter ended December 2024. Sales rose 9.28% to Rs 4,123 crore in Q3 FY26 as compared with Q3 FY25.

The scrip rose 0.35% to currently trade at Rs 391.70 on the BSE.

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