바카라 Bioepis wins Japanese marketing approval for autoimmune disease treatment ‘SB17’

[by Kang, In Hyo] Samsung Bioepis announced on December 23 that it has obtained marketing approval from the Japanese Ministry of Health, Labour and Welfare for ‘SB17’ (development code, ustekinumab), a biosimilar to Stelara indicated for the treatment of autoimmune diseases.

바카라 Bioepis plans to launch the Stelara biosimilar in Japan in May 2026 through its local commercialization partner, NIPRO Corporation. The two companies previously entered into a partnership agreement in June to commercialize the product in the Japanese market, marking 바카라 Bioepis' first collaboration with a local company for market entry in Japan.

Stelara, developed by the multinational pharmaceutical company Johnson & Johnson (J&J), is an 바카라 disease therapy that suppresses the activity of interleukin (IL)-12 and IL-23, key cytokines involved in immune signaling. Developed by the multinational pharmaceutical company Johnson & Johnson (J&J), Stelara is an 바카라 disease therapy that suppresses the activity of interleukin (IL)-12 and IL-23, which are key cytokines involved in immune signaling. Indicated for treating plaque psoriasis, psoriatic arthritis, and ulcerative colitis, Stelara has become a blockbuster biopharmaceutical, generating annual global sales of approximately 15 trillion KRW (10.361 billion USD).

바카라 Bioepis conducted a global Phase 3 clinical trial of SB17 involving 503 patients with plaque psoriasis across eight countries between July 2021 and November 2022. The results demonstrated clinical equivalence to the reference product, Stelara, confirming comparable efficacy and safety profiles.

"This regulatory approval will enhance treatment access for patients with autoimmune diseases in Japan and serve as an important milestone in strengthening our global footprint as a leading biosimilar company," said Jung Byoung-in, Executive Director and Director of Regulatory Affairs at Samsung Bioepis.

Conversely, Samsung Bioepis has subsequently commercialized its Stelara biosimilar in Europe and the United States under the brand name ‘Pyzchiva’ through its marketing partner, Sandoz. In Korea, the product is marketed directly by Samsung Bioepis under the brand name ‘Epyztek’.