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.
Read also: Biocon Chief Kiran Mazumdar Shaw condoles former Karnataka CM S M Krishna death
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.
Read also: Biocon sells 80 lacs equity shares of Syngene International for Rs 686 crores
Disclaimer: This website is primarily for healthcare professionals. The content here does not replace medical advice and should not be used as medical, diagnostic, endorsement, treatment, or prescription advice. Medical science evolves rapidly, and we strive to keep our information current. If you find any discrepancies, please contact us at corrections@medicaldialogues.in. Read our Correction Policy here. Nothing here should be used as a substitute for medical advice, diagnosis, or treatment. We do not endorse any healthcare advice that contradicts a physician's guidance. Use of this site is subject to our Terms of Use, Privacy Policy, and Advertisement Policy. For more details, read our Full Disclaimer here.
NOTE: Join us in combating medical misinformation. If you encounter a questionable health, medical, or medical education claim, email us at factcheck@medicaldialogues.in for evaluation.