Bengaluru, India: February 24, 2026
Biocon Limited, an innovation-led global biopharmaceuticals company, announced today that it has received approval from the U.S. FDA, 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, indicated as an adjunct to a reduced-calorie diet and increased physical activity.
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. The approval reinforces our commitment to expanding access to critical therapies for patients globally. We are fully committed to commercializing Liraglutide (gSaxenda®) at the earliest to ensure that patients in the U.S. benefit from a high-quality, affordable treatment option.
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.
About Glucagon-like peptide-1 (GLP-1):
Glucagon-like peptide-1 (GLP-1) are medications that help 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, maximizing nutrient absorption while limiting weight gain.
About 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 U.S. FDA in 2014, and by the EMA a year later, for adults who are either obese or overweight with atleast one weight-related condition. In 2019, it was approved by the U.S. 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.
About Biocon Limited:
Biocon Limited, publicly listed in 2004, (BSE code: 532523, NSE Id: BIOCON, ISIN Id: INE376G01013) is an innovation-led global biopharmaceuticals company committed to enhance affordable access to complex therapies for chronic conditions like diabetes, cancer and autoimmune. It has developed and commercialized novel biologics, biosimilars, and complex small molecule APIs in India and several key global markets as well as Generic Formulations in the US, Europe & key emerging markets. It also has a pipeline of promising novel assets in immunotherapy under development. Website: www.biocon.com