Biocon's YESINTEK™ Secures FDA Approval For Immune Disease Treatments

Biocon Biologics Ltd (BBL), a global biosimilars company and a subsidiary of Biocon Ltd, has announced that the U.S. Food and Drug Administration (FDA) has approved YESINTEK™ (Ustekinumab-kfce). The product is a biosimilar to the reference drug, Stelara® (Ustekinumab). YESINTEK™ is a monoclonal antibody indicated for treating Crohn’s disease, ulcerative colitis, plaque psoriasis, and psoriatic arthritis.

Previously, Biocon Biologics informed stock exchanges on February 29, 2024, about entering into a settlement and licensing agreement with Janssen Biotech Inc., Janssen Sciences Ireland, and Johnson & Johnson. Under this agreement, YESINTEK™ will be commercially available in the United States by February 22, 2025, following FDA approval.