Biocon Biologics, a fully integrated global biosimilars company and subsidiary of Biocon, has announced that the Medicines and Healthcare products Regulatory Agency (MHRA) has granted marketing authorisation in the United Kingdom (UK) for YESINTEK, a biosimilar of Ustekinumab.
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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 our 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 commercialisation in all European Union (EU) member states and the European Economic Area (EEA).