Biocon arm gets marketing nod in UK for plaque psoriasis drug Yesintek
Bengaluru: Biocon Biologics Ltd, a fully integrated global biosimilars company and subsidiary of Biocon Ltd., has received marketing authorisations in the United Kingdom (UK) for YESINTEK, a biosimilar of Ustekinumab.from the Medicines and Healthcare products Regulatory Agency (MHRA).
YESINTEK is indicated for the treatment of adults and children from the age of 6 years and older with moderate to severe plaque psoriasis, and adults with active psoriatic arthritis or moderately to severely active Crohn’s disease.
Clinical data from the trial program demonstrated that the Company's Ustekinumab biosimilar has comparable safety and efficacy to the originator product.
In Europe, the European Commission (EC) recently granted marketing authorisation for Ustekinumab, allowing its commercialization in all European Union (EU) member states and the European Economic Area (EEA).
In addition to progress in Europe, Biocon Biologics also secured multiple market access agreements in the US this month for Yesintek (ustekinumab-kfce), which was approved by the U.S. Food and Drug Administration (FDA) in December 2024.
Biocon Biologics is a global player in biosimilars and insulin production and has achieved many “firsts” in the industry including the first to receive approval of a trastuzumab in the United States, OGIVRI (Trastuzumab-dkst), as well as FULPHILA (Pegfilgrastim-jmdb) and the first U.S. approval of an interchangeable biosimilar for SEMGLEE (insulin glargine). Biocon Biologics has a comprehensive portfolio of in-market and in-development biosimilar products across multiple therapies, including seven approved biosimilars in the United States and six in Canada, with a development pipeline of 20 biosimilar assets, including insulins and monoclonal antibodies spanning multiple therapy areas.
