Samsung Bioepis gets OK to sell Stelara biosimilar in Europe

South Korea's Samsung Bioepis has received approval from the European Commission to sell Pyzchiva, a biosimilar of the autoimmune disease Stelara. 

This approval came two months after the Committee for Medicinal Products for Human Use (CHMP) under the European Medicines Agency (EMA) issued a positive opinion in February.

The latest approval increases the total number of the company's autoimmune disease biosimilars approved in Europe to four.

Sales of Pyzchiva in Europe will be managed by Samsung Bioepis' partner, Sandoz.

Stelara, a drug developed by the global pharmaceutical company Janssen, treats several conditions, including plaque psoriasis, psoriatic arthritis, Crohn's disease, and ulcerative colitis.

Samsung Bioepis currently markets a portfolio of seven commercialized biosimilars in Europe.

This portfolio comprises three treatments for autoimmune diseases (biosimilars of Enbrel, Remicade, and Humira), two oncology biosimilars (biosimilars of Herceptin and Avastin), one ophthalmic treatment (a biosimilar of Lucentis), and one for blood disorders (a biosimilar of Soliris).

Write to Dae-Kyu Ahn at powerzanic@hankyung.com