Samsung Bioepis Launches First Biosimilar in Japan

Sales Launched Through Partner “Nipro”
Follow-up Product Launch and Expansion of Global Presence

Samsung Bioepis announced on May 20 that it has launched the autoimmune disease treatment “SB17” (active ingredient: ustekinumab) in Japan through its local marketing partner, Nipro Corporation.

Autoimmune disease treatment SB17 launched in Japan. Samsung Bioepis

SB17 is a biosimilar of “Stelara,” originally developed by Johnson & Johnson. It is an autoimmune disease treatment that inhibits the activity of interleukin (IL)-12 and IL-23, which are cytokines involved in immune responses. Its approved indications include plaque psoriasis and psoriatic arthritis.

Samsung Bioepis received marketing authorization for SB17 for the treatment of plaque psoriasis and psoriatic arthritis from the Japanese Ministry of Health, Labour and Welfare in December 2025. The product was launched on this day following its inclusion in the National Health Insurance (NHI) drug reimbursement list on May 19.

In June 2025, Samsung Bioepis entered into a strategic partnership with Nipro and has since been pursuing the commercialization of multiple biosimilar products in Japan, including the Stelara biosimilar. With the first launch of SB17, the company is now accelerating its entry into the Japanese market.

Jinhan Jung, Senior Vice President of the Commercial Division at Samsung Bioepis, stated, “By providing high-quality biosimilar treatment options for Japanese patients with autoimmune diseases, we aim to improve treatment accessibility. We will continue to work toward meeting the unmet needs in various therapeutic areas.”

Samsung Bioepis is also marketing the Stelara biosimilar under the name “Pyzchiva™” in Europe and the United States, and as “Epyztek®” in Korea.

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