Biocon Biologics receives MHRA, UK approval for biosimilar YESINTEK

YESINTEK is indicated for the treatment of adults and children from the age of 6 years and olde

Biocon Biologics Ltd (BBL), a fully integrated global biosimilars company and subsidiary of Biocon Ltd., today 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 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).