Biocon informed in an exchange filing on Sunday that its drug has received approval from the US Food and Drug Administration (US FDA). Biocon Biologics has received approval from the US Food and Drug Administration (US FDA) for its biosimilar Ustekinumab. The company said in an exchange filing that Biocon Biologics Limited, an integrated global biosimilar company and a subsidiary of Biocon Limited, today announced that the US FDA has approved YESINTEK (Ustekinumab-kfce), a biosimilar to Stelara (Ustekinumab).
YESINTEK is a monoclonal antibody, approved for the treatment of Crohn's Disease, Ulcerative Colitis, Plaque Psoriasis and Psoriatic Arthritis. Biocon Biologics Limited had earlier informed the stock exchange on February 29, 2024 that the company has entered into an agreement and licensing agreement with Janssen Biotech Inc, Janssen Sciences Ireland and Johnson & Johnson to commercialize YESINTEK in the US after approval from the US FDA by February 22, 2025.
Stock performance The stock of the company closed at Rs 365.20 with a gain of 0.38 per cent on Friday. In the last one year, the stock of the company has seen a gain of 51.76 per cent. The 52-week high of the stock is Rs 395.65.
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