Biocon Biologics receives MHRA approval for Yesintek

Indian biosimilars developer Biocon Biologics, a subsidiary of Biocon Ltd  (BSE: 532520, today announced that the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) has granted marketing authorization for its Yesintek, a biosimilar of ustekinumab, which is marketed under the trade name Stelara by us healthcare giant Johnson & Johnson (NYSE: JNJ) .

Yesintek is indicated for the treatment of adults and children from the age of six 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 ustekinumab biosimilar has comparable safety and efficacy to the originator product.

With over a million people suffering from plaque psoriasis and approximately 500,000 suffering from Crohn’s disease in the UK, biosimilars play a critical role in improving patient access to essential medicines and reducing the financial burden on the NHS. Along with generics, biosimilars save the NHS up to £300 million ($405 million) a year, according to Biocon.