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Biocon has received approval from the US 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 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 commercializing Liraglutide (gSaxenda) at the earliest to ensure that patients in the US 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 US was US$ 127 million.
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