U.S. FDA Approves Biocon Biologics’ YESINTEK™, Bmab 1200 biosimilar to J&J’s Stelara® (Ustekinumab)

Sun, 01 Dec 2024
Posted by: Biocon Biologics
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NOTIFICATION TO STOCK EXCHANGE

COMPANY STATEMENT

Bengaluru, Karnataka, India, December 01, 2024

Biocon Biologics Ltd (BBL), a fully integrated global biosimilars company and subsidiary of Biocon Ltd (BSE code: 532523, NSE: BIOCON), announced today 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.

– Company Spokesperson

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Biocon Biologics

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