Samsung Bioepis, a subsidiary of Samsung Biologics, a leading biopharmaceutical company based in South Korea, has secured approval from the European Commission to market Pyzchiva, a biosimilar to the widely used autoimmune disease medication Stelara. This approval follows a positive opinion from the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) issued in February.
Pyzchiva is designed to treat multiple conditions, including plaque psoriasis, psoriatic arthritis, Crohn’s disease, and ulcerative colitis. The original drug, Stelara, was developed by Janssen, a global pharmaceutical leader. With this latest approval, Samsung Bioepis now boasts four autoimmune disease biosimilars approved for use in Europe.
Sales and distribution of Pyzchiva across Europe will be handled by Sandoz, Samsung Bioepis’ commercial partner. This strategic partnership is poised to leverage Sandoz’s established presence and sales network to effectively reach the European market.
Currently, Samsung Bioepis has a diverse portfolio of seven commercialized biosimilars in Europe, including treatments for autoimmune diseases, oncology, ophthalmic conditions, and blood disorders. This portfolio includes biosimilars of well-known drugs such as Enbrel, Remicade, Humira, Herceptin, Avastin, Lucentis, and Soliris.
The addition of Pyzchiva strengthens Samsung Bioepis’ position in the biopharmaceutical sector and underscores its commitment to providing accessible, cost-effective treatment alternatives for patients suffering from complex autoimmune diseases across Europe.
