Biocon Biologics Receives MHRA, UK Approval for Biosimilar Ustekinumab, YESINTEK®

Biocon Biologics Ltd (BBL), a fully integrated global biosimilars company and subsidiary of Biocon Ltd., announced that the Medicines and Healthcare products Regulatory Agency (MHRA) has granted marketing authorisations in the United Kingdom (UK) for YESINTEK®, a biosimilar of Ustekinumab. 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 Ustekinumab biosimilar has comparable safety and efficacy to the originator product. Recently, the European Commission (EC) granted marketing authorisation for Ustekinumab, allowing its commercialization in all European Union (EU) member states and the European Economic Area (EEA).