FDA approves Yesintek, a biosimilar to the reference product, Stelara – Biocon Biologics

Biocon Biologics Ltd , a fully integrated global biosimilars company and subsidiary of Biocon Ltd, announced  that the 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 notified the Stock Exchange 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 of America no later than on February 22, 2025, upon approval from the U.S. FDA.

The FDA has approved Yesintek (ustekinumab-kfce), the sixth biosimilar to reference Stelara (ustekinumab) for patients with inflammatory bowel disease (IBD), plaque psoriasis, and psoriatic arthritis.