Biocon Receives US FDA Approval for Generic Weight Loss Drug Liraglutide

Biocon Ltd announced on Tuesday that it has received approval from the US Food and Drug Administration for its complex formulation Liraglutide Injection, 18 mg/3 mL (6 mg/mL) single-patient-use prefilled pens, marketed as gSaxenda.

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

Glucagon-like peptide-1 (GLP-1) medications help lower blood sugar levels and promote weight loss. These physiological hormones have multiple actions on glucose mediated by the GLP-1 receptors released from gut enteroendocrine cells. They control meal-related glycemic excursions through the augmentation of insulin secretion and inhibition of glucagon secretion. GLP-1 also inhibits gastric emptying and food intake, maximizing nutrient absorption while limiting weight gain.

Liraglutide is a synthetic analog of the GLP-1 peptide administered as a once-daily injection. It was approved for medical use in the European Union in 2009 and in the U.S. in 2010. The US FDA approved Liraglutide for weight management in 2014, and the European Medicines Agency (EMA) granted approval a year later. The indication covers adults who are either obese or overweight with at least one weight-related condition.

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