The FDA has approved Yesintek (Ustekinumab-kfce), a biosimilar to Stelara® (Ustekinumab), developed by Biocon Biologics Ltd (BBL), a subsidiary of Biocon Ltd.
The biosimilar is indicated for the treatment of Crohn's disease, ulcerative colitis, plaque psoriasis, and psoriatic arthritis.
Yesintek is a monoclonal antibody. Biocon Biologics, based in Karnataka, India, had previously disclosed on February 29, 2024, that it entered into a settlement and licensing agreement with Janssen Biotech Inc., Janssen Sciences Ireland, and Johnson & Johnson to commercialize in the U.S. "no later than" February 22, 2025, contingent on FDA approval according to a company statement.