USFDA approves Biocon Biologics Yesintek for Crohn's disease, Ulcerative Colitis, Plaque Psoriasis, Psoriatic Arthritis

Bengaluru: Biocon Biologics Ltd, a fully integrated global biosimilars company and subsidiary of Biocon Ltd, has announced that the U.S. Food and Drug Administration (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 Feb 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.

Medical Dialogues team had earlier reported that had received approval from the European Medicines Agency (EMA) to manufacture biosimilar Bevacizumab at its new, world-class, multi-product monoclonal antibodies (mAbs) drug substance facility at Bengaluru.

Read also: USFDA classifies Biocon Biologics Biocon Park Site in Bengaluru as VAI

Biocon Limited, publicly listed in 2004, is an innovation-led, global biopharmaceutical company. It has developed and commercialized novel biologics, biosimilars and complex small molecule APIs in India and several key global markets, as well as generic formulations in the US and Europe.