15 December 2024 - Biocon Biologics today announced that the EMA’s 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, 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.