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U.S. FDA Approves Ustekinumab Biosimilar for Psoriasis, PsA

The U.S. Food and Drug Administration approved Biocon Biologics’ Yesintek, Bmab 1200 Biosimilar to ustekinumab (Stelara, J & J).

Yesintek, a monoclonal antibody, is approved for the treatment of plaque psoriasis, psoriatic arthritis.  Crohn’s disease, and ulcerative colitis.

Biocon Biologics Ltd had previously announced  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.