Biocon Ltd

Biocon Pharma, a wholly owned subsidiary of Biocon Ltd., has received tentative approval from the U.S. Food and Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) for Rifaximin Tablets, 550 mg. Developed in partnership with Carnegie Pharmaceuticals LLC, this generic antibacterial medication is indicated for reducing the risk of overt hepatic encephalopathy (HE) recurrence and treating irritable bowel syndrome with diarrhea (IBS-D) in adults. While the approval signifies compliance with regulatory standards, the product cannot be marketed in the U.S.

Biocon Ltd., India’s pioneering biopharmaceutical firm, has successfully concluded a Qualified Institutions Placement (QIP) worth Rs. 4,500 crore—its first equity fundraise since going public in 2004. The offering, which drew significant interest from both domestic and global institutional investors, reinforces the market’s confidence in Biocon’s strategic direction and global ambitions.

Biocon has obtained approval from the Drugs Controller General of India (DCGI) for its generic version of Liraglutide, a medication used to manage Type 2 Diabetes Mellitus across various age groups. This regulatory milestone, covering both the active drug substance and the injectable drug product through its subsidiary Biocon Pharma, marks a significant advance in the company’s mission to enhance treatment accessibility in India—home to over 77 million diabetes patients.

Biocon Ltd., India’s leading biopharmaceutical enterprise, reported a more than twofold rise in consolidated net profit for the quarter ending March 31, 2025, driven by resilient performance across its core business segments. Quarterly net profit soared to Rs. 344 crore, compared to Rs. 136 crore in the same period last year. Despite a marginal decline in annual profit, revenue growth remained solid. The company announced strategic plans for internal restructuring, including a potential merger with its biosimilar arm, Biocon Biologics, and a proposed fundraising initiative worth Rs.

Biocon Ltd, through its biologics subsidiary Biocon Biologics Ltd, has made a significant entrance into the U.S. biosimilars landscape with the launch of Yesintek (ustekinumab-kfce), a biosimilar to Stelara. Approved for the treatment of several autoimmune conditions including Crohn’s disease, ulcerative colitis, plaque psoriasis, and psoriatic arthritis, Yesintek has secured broad market access across major U.S. insurance formularies.