Approval of Biocon Biologics Yesintek recommended by EMA Committee

Bengaluru: Biocon Biologics Ltd, a fully integrated global biosimilars company and subsidiary of Biocon Ltd, has announced that the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) has issued a positive opinion recommending approval of YESINTEK, an Ustekinumab biosimilar intended for the treatment of adults and children with plaque psoriasis and adults with psoriatic arthritis or Crohn’s disease - based on the application filed by Biosimilar Collaborations Ireland Limited, an indirect wholly owned subsidiary of Biocon Biologics.

Clinical studies showed that the Ustekinumab biosimilar has a similar pharmacokinetic, safety, efficacy and immunogenicity profile compared with the originator product.

Detailed recommendations for the use of YESINTEK will be described in the summary of product characteristics (SmPC), which will be published in the European public assessment report (EPAR) and made available in all official European Union languages after the marketing authorisation has been granted by the European Commission.

The CHMP positive opinion follows recent approval by the U.S. FDA earlier this month. In which, YESINTEK, a monoclonal antibody, was 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.

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