The U.S. Food and Drug Administration (FDA) has approved Biocon Biologics’ YESINTEK™ (ustekinumab-kfce), a biosimilar to Stelara® (ustekinumab). YESINTEK™ is authorized for treating Crohn’s disease, ulcerative colitis, plaque psoriasis, and psoriatic arthritis.
✏️▫️Clinical trials have demonstrated that YESINTEK™ is equivalent to Stelara® in terms of efficacy, safety, immunogenicity, and pharmacokinetics. A phase 3 randomized, double-blind, multicenter study evaluated the biosimilar against the reference biologic in 384 adult patients with moderate to severe chronic plaque psoriasis, confirming comparable profiles between the two treatments.
✏️▫️This approval marks the sixth biosimilar referencing Stelara®. Biocon Biologics plans to launch YESINTEK™ in the United States by following a settlement and licensing agreement with Janssen Biotech Inc., Janssen Sciences Ireland, and Johnson & Johnson.This approval and agreement enable Biocon Biologics to provide a cost-effective alternative for patients, expanding access to vital therapies for chronic inflammatory diseases.
This approval and agreement enable Biocon Biologics to provide a cost-effective alternative for patients, expanding access to vital therapies for chronic inflammatory diseases