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

BRIDGEWATER, N.J. and BENGALURU, India, Dec. 2, 2024 /PRNewswire/ -- Biocon Biologics Ltd (BBL), a fully integrated global biosimilars company and subsidiary of Biocon Ltd (BSE code: 532523, NSE: BIOCON), announced today 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 announced on February 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 no later than on February 22, 2025, upon approval from the U.S. FDA.

SOURCE Biocon Biologics Ltd.

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