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

Core Insights - Biocon Biologics Ltd has received FDA approval for YESINTEK™ (Ustekinumab-kfce), a biosimilar to Stelara® (Ustekinumab) [1][2] - YESINTEK™ is indicated for the treatment of Crohn's disease, ulcerative colitis, plaque psoriasis, and psoriatic arthritis [2] Company Developments - The company had previously announced a settlement and licensing agreement with Janssen Biotech Inc., Janssen Sciences Ireland, and Johnson & Johnson to commercialize YESINTEK™ in the U.S. by February 22, 2025, following FDA approval [2]