Biocon Biologics (BBL), a global leader in biosimilars and a division of Biocon Ltd, has declared that the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has rendered a favorable opinion, endorsing the approval of Yesintek—an Ustekinumab biosimilar designed for treating plaque psoriasis in both adults and pediatric patients, as well as psoriatic arthritis or Crohn’s disease in adults. This follows an application submitted by Biosimilar Collaborations Ireland Limited, an entirely owned subsidiary of BBL.
Research has demonstrated that the Ustekinumab biosimilar exhibits comparable pharmacokinetics, safety, efficacy, and immunogenicity to the original product. Detailed guidance for using Yesintek will be included in the summary of product characteristics (SmPC), due to be released in the European public assessment report (EPAR). This information will be accessible in all official languages of the European Union once the marketing authorization is issued by the European Commission. According to a company representative, this positive opinion from CHMP follows a recent approval granted by the US FDA earlier this month.