Samsung Bioepis’ Autoimmune Disease Treatment ‘PYZCHIVA’ Approved in the U.S.

Samsung Bioepis has announced that its biosimilar to Stelara, named ‘Pyzchiva’ (project name SB17, active ingredient ustekinumab), has received approval from the U.S. Food and Drug Administration (FDA) on the 2nd of this month.

The original drug, Stelara, developed y Janssen, is a treatment for autoimmune diseases such as plaque psoriasis, psoriatic arthritis, and Crohn's disease. It works by inhibiting the activity of interleukin (IL)-12 and 23, neurotransmitters involved in immune response. Stelara has an annual global revenue of approximately 14 trillion won.

With this approval, Samsung Bioepis has now secured a total of seven product approvals in the United States. Previously, the company obtained approvals for three autoimmune disease treatments (biosimilars to Enbrel, Remicade, and Humira), one cancer treatment (a biosimilar to Herceptin), and two ophthalmic treatments (biosimilars to Lucentis and Eylea).

Jeong Byung-in, Senior Vice President and Head of Regulatory Affairs at Samsung Bioepis, stated, "We are pleased to have received FDA approval for Pyzchiva, our first interleukin inhibitor among autoimmune treatments, in the U.S. We will continue to strive to provide more treatment options to patients by developing a diverse range of pharmaceuticals."

Prior to this, Samsung Bioepis had obtained approvals for Pyzchiva in Europe (under the name Pyzchiva) and Korea (under the name Epizetec) in April. The company plans to launch Pyzchiva in Korea later this month.