Biocon Limited has received approval from the United States Food and Drug Administration (U.S. FDA) 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 indicated for chronic weight management as an adjunct to a reduced-calorie diet and increased physical activity. The approval marks Biocon’s entry into the U.S. market for GLP-1 receptor agonists in the weight management segment.
The company plans to commercialize Liraglutide in the U.S. at the earliest to provide a high-quality, more affordable treatment option.
GLP-1 receptor agonists have emerged as one of the fastest-growing therapeutic categories globally, driven by the increasing prevalence of obesity and metabolic disorders, robust clinical outcomes, and growing physician adoption. According to IQVIA MAT December 2025 data, the total addressable U.S. market opportunity for GLP-1 therapies in weight loss was estimated at $127 million.
Glucagon-like peptide-1 (GLP-1) medications help lower blood glucose levels and promote weight loss. These physiological hormones act through GLP-1 receptors released from gut enteroendocrine cells.
They regulate post-meal blood sugar levels by enhancing insulin secretion and suppressing glucagon release. GLP-1 therapies also slow gastric emptying and reduce food intake, supporting improved glycemic control and weight reduction.
The company described the approval as a significant milestone that underscores its scientific and manufacturing capabilities in developing complex formulations. It also aligns with Biocon’s strategy to expand its presence in the fast-growing GLP-1 therapeutic class, with the United States identified as a key market.
