Samsung Bioepis Launches Stelara Biosimilar 'Fizchiva' in the US

Expansion into the U.S. Market Following Success in Europe and Korea

Samsung Bioepis Fizecheva US product. Photo by Samsung Bioepis

Samsung Bioepis announced on the 25th that it has launched the autoimmune disease treatment 'Pizchiva' (generic name ustekinumab) in the United States through its marketing partner, Sandoz.

Pizchiva is a biosimilar of Stelara. Stelara, developed by Janssen, is an autoimmune disease treatment for plaque psoriasis, psoriatic arthritis, Crohn's disease, and ulcerative colitis, with an annual global sales volume of $10.361 billion (approximately 15 trillion KRW) and U.S. sales of $6.72 billion (approximately 10 trillion KRW). Pizchiva is an autoimmune disease treatment that works by inhibiting the activity of interleukin (IL)-12 and IL-23, types of inflammatory cytokines involved in immune responses.

With the launch of Pizchiva, Samsung Bioepis has introduced its third autoimmune disease treatment, following two tumor necrosis factor alpha (TNF-α) inhibitors. Including oncology and ophthalmology treatments, this marks the fifth product launch in the U.S. market, expanding its portfolio in the United States.

Samsung Bioepis headquarters building. Photo by Samsung Bioepis

Linda Y. MacDonald, Vice President and Head of Commercial at Samsung Bioepis, stated, "The U.S. launch of Pizchiva provides autoimmune disease patients with diverse treatment opportunities. Expanding treatment options is expected to reduce healthcare costs and ultimately contribute to a sustainable healthcare system. We will continue to strive to address unmet needs in the U.S. pharmaceutical market."

Meanwhile, Samsung Bioepis also sells Pizchiva (European product name PYZCHIVA™) in Europe through Sandoz, holding a 43% market share among Stelara biosimilars in Europe, ranking first in the biosimilar market.

Additionally, in South Korea, Samsung Bioepis launched Epiztec® (the domestic product name for the Stelara biosimilar) last July through a direct sales system, offering it at approximately 40% lower price compared to the original drug.

This content was produced with the assistance of AI translation services.