Samsung Bioepis Receives Japanese Approval for Autoimmune Disease Treatment

Scheduled for Launch in Japan Next May Through Local Marketing Partner

Samsung Bioepis announced on December 23 that it has received product approval from Japan’s Ministry of Health, Labour and Welfare for its Stelara biosimilar (ingredient: ustekinumab), a treatment for autoimmune diseases.

Exterior view of Samsung Bioepis building in Yeonsu-gu, Incheon. Samsung Bioepis

Stelara is a treatment for autoimmune diseases that inhibits the activity of interleukin (IL)-12 and IL-23, which are cytokines involved in immune response signaling. It is approved for indications such as plaque psoriasis, psoriatic arthritis, and ulcerative colitis. It is a blockbuster biopharmaceutical with annual global sales of approximately 15 trillion won.

Samsung Bioepis plans to launch the Stelara biosimilar in Japan in May next year through its local commercial partner, Nipro Corporation. Previously, the two companies signed a partnership agreement in June to commercialize the product in the Japanese market. This marks the first time Samsung Bioepis has collaborated with a local company to enter the Japanese market.

Jung Byungin, Head of Regulatory Affairs at Samsung Bioepis, said, "With this product approval, we can enhance treatment accessibility for Japanese patients with autoimmune diseases and establish an important foothold for expanding our presence in the global market as a leading company in the biosimilar industry."

Meanwhile, Samsung Bioepis conducted a global Phase 3 clinical trial of SB17 from July 2021 to November 2022, involving 503 patients with plaque psoriasis across eight countries. The study confirmed the clinical equivalence of efficacy and safety between the biosimilar and the original drug.