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Biocon Biologics, a fully integrated global biosimilars company and subsidiary of Biocon received the approval from the UK Medicines and Healthcare products Regulatory Agency (MHRA) to market Yesintek, a biosimilar of ustekinumab in the United Kingdom.
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 programme 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 commercialization in all European Union (EU) member states and the European Economic Area (EEA), said the company spokesperson.
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