Biocon Biologics Ltd (BBL) on Sunday announced that the U.S. Food and Drug Administration (FDA) has approved YESINTEK (Ustekinumab-kfce), a biosimilar to the reference product, Stelara (Ustekinumab).
According to the company’s statement, YESINTEK, a monoclonal antibody, is approved for the treatment of Crohn’s disease, Ulcerative Colitis, Plaque Psoriasis and Psoriatic Arthritis.
A company spokesperson stated that Biocon Biologics Ltd had previously notified the Stock Exchange on Feb 29, 2024, that the Company had 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.
