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European Commission Approves Biocon Biologics’ Ustekinumab Biosimilar
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Tue, 18-Feb-2025
- Posted by: Biocon Biologics
NOTIFICATION TO STOCK EXCHANGE
COMPANY STATEMENT
Bengaluru, Karnataka, India, February 18, 2025
Biocon Biologics Ltd (BBL), a fully integrated global biosimilars company and subsidiary of Biocon Ltd (BSE code: 532523, NSE: BIOCON), announced today that the European Commission (EC) granted marketing authorisation in the European Union (EU) for YESINTEK®, a biosimilar of Ustekinumab.
YESINTEK®, is intended for the treatment of adults and children with plaque psoriasis and adults with psoriatic arthritis or Crohn’s disease. Clinical data from the trial program showed that Ustekinumab biosimilar has comparable safety and efficacy to the originator product.
The marketing authorisation approval follows a positive opinion from the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) issued on December 14, 2024.
– Company Spokesperson
YESINTEK is a registered trademark of Biocon Biologics Limited.
All other trademarks, registered or unregistered, are the property of their respective owners.
For more information: seema.ahuja@biocon.com
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