European Commission approves Biocon Biologics' Ustekinumab Biosimilar
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European Commission approves Biocon Biologics' Ustekinumab Biosimilar

YESINTEK, is intended for the treatment of adults and children with plaque psoriasis and adults with psoriatic arthritis or Crohn's disease

  • By IPP Bureau | February 21, 2025

Biocon Biologics Ltd (BBL), a fully integrated global biosimilars company and subsidiary of Biocon Ltd announced 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.

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