U.S.FDA Approves Biocon Biologics’ YESINTEK™, Bmab 1200 Biosimilar to J&J's Stelara®

Biocon Biologics Ltd (BBL), a fully integrated global biosimilars company and subsidiary of Biocon Ltd, announced that the U.S. Food and Drug Administration (FDA) has approved YESINTEK™ (Ustekinumab-kfce), a biosimilar to the reference product, Stelara® (Ustekinumab). YESINTEK™, a monoclonal antibody, is approved for the treatment of Crohn’s disease, Ulcerative Colitis, Plaque Psoriasis and Psoriatic Arthritis. Biocon Biologics Ltd had previously entered into a settlement and licensing agreement with Janssen Biotech Inc., Janssen Sciences Ireland, and Johnson & Johnson (collectively known as Janssen) to commercialize YESINTEK™ in the United States of America no later than on February 22, 2025, upon approval from the U.S. FDA.