Samsung Bioepis has officially commenced its full-scale entry into the Japanese market with the launch of its autoimmune disease treatment, SB17, in collaboration with Nipro Corporation. This marks a significant milestone as the company’s inaugural product introduction in Japan.
SB17 is a cutting-edge biosimilar that references Stelara (ustekinumab), designed to effectively treat various immune-mediated conditions, including plaque psoriasis and psoriatic arthritis. The drug’s mechanism of action involves specifically inhibiting interleukin-12 and interleukin-23, crucial proteins known to drive abnormal immune responses.
This strategic launch follows a comprehensive partnership agreement forged between Samsung Bioepis and Nipro in June 2025, aimed at commercializing multiple biosimilar products, including the Stelara biosimilar, across Japan.
Regulatory approval for SB17 was granted by Japan’s Ministry of Health, Labour and Welfare in December, specifically endorsing it for the treatment of plaque psoriasis and psoriatic arthritis. The product’s market availability was cemented after its inclusion in Japan’s National Health Insurance reimbursement scheme, effective this past Monday, enhancing patient access nationwide.
Chung Jin-han, Head of Commercial Strategy for International Markets at Samsung Bioepis, expressed enthusiasm regarding this pivotal development: “We are thrilled to announce the launch of our first biosimilar product in Japan in partnership with Nipro. Together, we are committed to supporting patients living with autoimmune diseases and bolstering the sustainability of Japan’s health care system by offering quality-assured, safe, and effective biosimilar options.”
