Biocon Biologics (BBL), a global biosimilars company and a subsidiary of Biocon, has announced that the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has issued a positive opinion recommending the approval of YESINTEK. The Ustekinumab biosimilar is intended for the treatment of adults and children with plaque psoriasis, as well as adults with psoriatic arthritis or Crohn’s disease.
The positive opinion is based on the application submitted by Biosimilar Collaborations Ireland, an indirect wholly owned subsidiary of Biocon Biologics. Clinical studies have demonstrated that YESINTEK has a similar pharmacokinetic, safety, efficacy, and immunogenicity profile compared to the originator product.
Once the European Commission grants marketing authorisation, detailed recommendations for the use of YESINTEK will be outlined in the summary of product characteristics (SmPC). This information will be published in the European public assessment report (EPAR) and made available in all official European Union languages.
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