Samsung Bioepis‘ biosimilar wins EMA’s positive opinion

[Courtesy of Samsung Bioepis Co.]

Samsung Bioepis Co. said on Sunday that its medicinal product Pyzchiva (Ustekinumab) won a positive opinion from the European Medicines Agency (EMA)’s Committee for Medicinal Products for Human Use (CHMP). The opinion recommends the granting of a marketing authorization for the product that treats plaque psoriasis, including paediatric plaque psoriasis, psoriatic arthritis, ulcerative colitis, and Crohn‘s disease in adults.

Pyzchiva is a biosimilar product referencing Johnson & Johnson Innovative Medicine (formerly Janssen Pharmaceuticals)’s Stelara (Ustekinumab). The biosimilar’s active substance is an immunosuppressant interleukin inhibitor that binds to the shared p40 protein subunit of interleukin (IL)-12 and IL-23, thereby preventing them from binding to the IL‑12Rβ1 receptor protein expressed on the surface of immune cells.

Pyzchiva is the fourth immunosuppressant drug that Samsung Bioepis has on the market, including SB2 (infliximab), a biosimilar of Remicade. The company now has a total of seven biosimilar products in the European market.