EMA's CHMP Recommends Approval of Biocon Biologics’ YESINTEK®, a Biosimilar to J&J's Stelara®

Biocon Biologics Ltd (BBL), a fully integrated global biosimilars company and subsidiary of Biocon Ltd, 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. The biosimilar is intended for the treatment of adults and children with plaque psoriasis and adults with psoriatic arthritis or Crohn’s disease. The recommendation is based on the application filed by Biosimilar Collaborations Ireland Limited, an indirect wholly owned subsidiary of BBL. Clinical studies have shown that the Ustekinumab biosimilar has a similar pharmacokinetic, safety, efficacy and immunogenicity profile compared with the originator product. The detailed recommendations for the use of YESINTEK® will be described in the summary of product characteristics (SmPC) after the marketing authorisation has been granted by the European Commission. This positive opinion follows recent approval by the U.S. FDA earlier this month.