The European Commission (EC) has approved Biocon Biologics’ Yesintek, an ustekinumab biosimilar referencing Johnson & Johnson’s Stelara, to treat multiple inflammatory diseases.

Yesintek has been authorised to treat moderate-to-severe plaque psoriasis in adults and children aged six years and older whose condition has not improved with, or who are unable to use, other systemic treatments, as well as to treat active psoriatic arthritis in adults whose condition has not improved enough with disease-modifying anti-rheumatic drugs.

Plaque psoriasis occurs in up to 90% of psoriasis patients and is characterised by distinct plaques that are usually covered with silvery scales, while psoriatic arthritis, which causes joint pain, stiffness and swelling, affects up to 30% of psoriasis patients.

Ustekinumab is designed to block the activity of interleukin 12 and interleukin 23, which are thought to play an important role in inflammation.

A biosimilar, according to the European Medicines Agency (EMA), is a biological medicine that is highly similar to one already approved in the EU. This means patients can expect the same safety and effectiveness from the biosimilar as they would from the reference product.

The EC’s decision on Yesintek, which is also now approved to treat certain cases of Crohn’s disease, follows a recent recommendation from the EMA’s human medicines committee and was supported by clinical data showing that Biocon’s drug has comparable safety and efficacy to Stelara.

“The EMA decided that, in accordance with EU requirements for biosimilar medicines, Yesintek has a highly similar structure, purity and biological activity to Stelara and is distributed in the body in the same way,” the EU regulator said in its prescribing information.