Biocon Biologics receives FDA approval for biosimilar YESINTEK

Biocon Biologics, a global biosimilars company and subsidiary of Biocon, has announced that the U.S. Food and Drug Administration (FDA) has approved YESINTEK (Ustekinumab-kfce). The biosimilar is a monoclonal antibody designed to treat Crohn’s disease, ulcerative colitis, plaque psoriasis, and psoriatic arthritis.

The company had previously informed the Stock Exchange on 29 February 2024 about its settlement and licensing agreement with Janssen Biotech, Janssen Sciences Ireland, and Johnson & Johnson (collectively Janssen). Under the agreement, Biocon Biologics is authorised to commercialise YESINTEK in the United States no later than 22 February 2025, following FDA approval.

YESINTEK is a biosimilar to Stelara (Ustekinumab), a reference product developed by Janssen. The approval and agreement enable Biocon Biologics to expand its presence in the U.S. biosimilars market.