FDA approves Biocon biosimilar Yesintek

Biocon Biologics the biosimilars company and subsidiary of Indian drugmaker Biocon (BSE: 532523), has announced that the US Food and Drug Administration (FDA) has approved Yesintek (ustekinumab-kfce), a biosimilar to the reference product, Stelara (ustekinumab) from Johnson & Johnson (NYSE: JNJ). The news sent Biocon’s shares up 2.6% to 374.50 rupees.

Yesintek, a monoclonal antibody, is approved for the treatment of Crohn’s disease, ulcerative colitis, plaque psoriasis and psoriatic arthritis.

Biocon Biologics had previously notified the Stock Exchange on Feb 29, 2024, that the Company had entered into a settlement and licensing agreement with Janssen Biotech, Janssen Sciences Ireland, and Johnson & Johnson (collectively known as Janssen) to commercialize Yesintek in the USA no later than on February 22, 2025, upon approval from the US FDA.