BENGALURU: Biocon Biologics, a biosimilars company and 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 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.
It said clinical studies showed the Ustekinumab biosimilar has a similar pharmacokinetic, safety, efficacy and immunogenicity profile compared with the originator product.
This follows the recent approval by the US Food and Drug Administration (FDA) earlier this month. It has approved YESINTEK, a monoclonal antibody, which is approved for the treatment of Crohn’s disease, Ulcerative Colitis, Plaque Psoriasis and Psoriatic Arthritis.
The company spokesperson said the 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).