Biocon wins USFDA approval for generic weight-loss drug Liraglutide

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The approval comes as Biocon is simultaneously executing a major corporate restructuring: the merger of Biocon Limited and its subsidiary Biocon Biologics.

The approval comes as Biocon is simultaneously executing a major corporate restructuring: the merger of Biocon Limited and its subsidiary Biocon Biologics.
| Photo Credit:
DHIRAJ SINGH

Biocon Limited on Tuesday received USFDA approval for its generic version of Liraglutide Injection (18 mg/3 mL), a GLP-1 weight management drug sold under the brand name Saxenda, marking the company’s entry into the high-growth US obesity treatment market. The Bengaluru-based biopharmaceutical company’s stock was trading at ₹391.10 on the NSE on Wednesday, up marginally by 0.09 per cent from the previous close of ₹390.75.

The approved product, gSaxenda, is a drug-device combination delivered via single-patient-use prefilled pens and is indicated as an adjunct to a reduced-calorie diet and increased physical activity for chronic weight management. According to IQVIA data for the 12 months ending December 2025, the total addressable market for GLP-1 weight loss therapies in the US stands at $127 million.

CEO and Managing Director Siddharth Mittal called the approval a “defining milestone,” citing the company’s vertically integrated development and manufacturing platform as a key enabler. Biocon has stated its intent to commercialise the product at the earliest.

The approval comes as Biocon is simultaneously executing a major corporate restructuring; the merger of Biocon Limited and its subsidiary Biocon Biologics; aimed at simplifying its structure and eliminating a holding company discount. The combined entity is positioned to offer a portfolio of over 30 biosimilars and three GLP-1 products, targeting a total addressable market of over $200 billion.

Financially, the group reported revenues of $1,422 million for the nine months ended December 2025, with biosimilars contributing 61 per cent of the total. EBITDA margin stood at 21 per cent for the same period. Net debt-to-EBITDA improved to 2.8x from 4.3x in FY23, reflecting the impact of a ₹4,500 crore QIP and debt refinancing undertaken over the past two years.

The investor presentation also noted that Semaglutide, another GLP-1 product, has a Drug Master File filed in the US and remains a pipeline priority.

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Published on February 25, 2026



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