Samsung Bioepis said it received marketing authorization from Japan's Ministry of Health, Labour and Welfare for a biosimilar of the autoimmune disease treatment "Stelara."
The approved product is a biosimilar with the active ingredient ustekinumab, and its product name in Japan is "Ustekinumab BS subcutaneous injection 45 milligrams syringe Nipro."
Stelara is an autoimmune disease treatment that inhibits the activity of interleukin (IL)-12 and IL-23, which are involved in the immune response, and is used for plaque psoriasis, psoriatic arthritis, and ulcerative colitis. Developed by Johnson & Johnson, the original drug is known to generate about 15 trillion won in global annual sales.
Samsung Bioepis plans to launch the biosimilar in the Japanese market in May next year through its local commercial partner Nipro Corporation. The two companies signed a partnership agreement in June for commercialization in the Japanese market. This is the first time Samsung Bioepis has collaborated with a local company to enter the Japanese market.
From July 2021 to Nov. 2022, the company conducted a global phase 3 trial of the product in eight countries with 503 patients with plaque psoriasis. It said the trial confirmed clinical equivalence, including efficacy and safety, to the original drug.
Samsung Bioepis has already launched a biosimilar with the same ingredient in Europe and the United States under the product name "Pyzchiva" through Sandoz, and sells it directly in Korea under the name "Epyztek."