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Biocon receives USFDA approval for Liraglutide injection gSaxenda for weight managementBiocon Ltd received USFDA approval for Liraglutide Injection gSaxenda, marking a milestone in chronic weight management. Siddharth Mittal highlights US market growth and global patient access.By Jomy Jos Pullokaran  February 24, 2026, 10:30:01 PM IST (Published)3 Min ReadBiotech firm Biocon Ltd on Tuesday (February 24) announced that it has received approval from the US Food and Drug Administration (USFDA) for its complex formulation Liraglutide Injection, 18 mg/3 mL (6 mg/mL) single-patient-use prefilled pens (gSaxenda).

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

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

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

Siddharth Mittal, Chief Executive Officer and Managing Director, Biocon Ltd, 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 US being an important market in this strategy. The approval reinforces our commitment to expanding access to critical therapies for patients globally. We are fully committed to commercialising Liraglutide (gSaxenda) at the earliest to ensure that patients in the US benefit from a high-quality, affordable treatment option."

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What is Glucagon-like peptide-1 (GLP-1)?

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

What is Liraglutide?

Liraglutide is a synthetic analog of GLP-1 peptide and is administered as a once-daily injection. It was approved for medical use in the European Union in 2009 and in the United States in 2010.

Liraglutide was approved by the US FDA in 2014 and by the EMA a year later for adults who are either obese or overweight with at least one weight-related condition. In 2019, it was approved by the US FDA for the treatment of children who are ten years or older with type 2 diabetes, making it the first non-insulin drug approved to treat type 2 diabetes in children since metformin was approved in 2000.

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Shares of Biocon Ltd ended at ₹390.35, up by ₹2.55, or 0.66%, on the BSE.Continue Reading(Edited by : Jomy Jos Pullokaran)TagsBioconshare market today