Samsung Bioepis announced on the 23rd that the European Commission (EC) granted marketing authorization for its Stelara biosimilar Pyzchiva.

The final marketing authorization comes 2 months after Pyzchiva received a positive opinion for marketing authorization from the European Medicines Agency (EMA)’s Committee for Medicinal Products for Human Use (CHMP) in February.

Pyzchiva’s original drug Stelara, which was developed by Janssen, is an autoimmune disease treatment for plaque psoriasis, psoriatic arthritis, Crohn's disease, and ulcerative colitis. It inhibits the activity of interleukin (IL)-12,23, a class of proinflammatory cytokines involved in the adaptive immune response.