Biocon Gets USFDA Nod for gSaxenda, Enters US GLP-1 Weight Loss Market
New Delhi: Biocon Limited has secured approval from the U.S. Food and Drug Administration (USFDA) for its complex formulation Liraglutide Injection, 18 mg/3 mL (6 mg/mL) single-patient-use prefilled pens, branded as gSaxenda, marking its entry into the United States GLP-1 weight management segment.
Liraglutide is a drug-device combination formulation indicated for chronic weight management as an adjunct to a reduced-calorie diet and increased physical activity.
Announcing the approval, 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 U.S. being an important market in this strategy.”
He added that the company is fully committed to commercializing Liraglutide (gSaxenda®) at the earliest to ensure access to a high-quality, affordable treatment option for patients in the U.S.
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 data, the total addressable market opportunity for GLP-1 therapies in weight loss in the U.S. stood at approximately USD 127 million.
Glucagon-like peptide-1 (GLP-1) medications help lower blood sugar levels and promote weight loss. These physiological hormones act on GLP-1 receptors released from gut enteroendocrine cells, augment insulin secretion, inhibit glucagon release, delay gastric emptying, and reduce food intake—thereby improving glycemic control while supporting weight reduction.
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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 United States in 2010. In 2014, the USFDA approved liraglutide for chronic weight management in adults who are obese or overweight with at least one weight-related condition. In 2019, it was approved in the U.S. for treating children aged 10 years and above with type 2 diabetes, becoming the first non-insulin therapy cleared for pediatric type 2 diabetes since metformin’s approval in 2000.
The approval strengthens Biocon’s position in the GLP-1 space, a key strategic focus area for the company as it expands its complex formulations and metabolic portfolio in regulated markets.
Biocon Limited, is a global biopharmaceutical company focused on improving affordable access to therapies for chronic conditions such as diabetes, cancer, and autoimmune diseases. The company has developed and commercialized novel biologics, biosimilars, complex APIs, and generic formulations across major global markets, with an advancing pipeline in immunotherapy and other specialty segments.
