Samsung Bioepis Launches First Product In Japan Under NIPRO Partnership

KUALA LUMPUR, May 20 (Bernama) -- Samsung Bioepis Co Ltd has launched Ustekinumab BS 45 mg Syringe for S.C. Injection「 NIPRO」, a biosimilar referencing Stelara (ustekinumab), marking its first product launch in Japan with NIPRO Corporation (NIPRO).

According to Samsung Bioepis in a statement, the launch follows the product’s listing under Japan’s National Health Insurance (NHI) Drug Price Standard, which became effective following an Official Gazette announcement on May 19.

“Together with our partner NIPRO, we look forward to supporting patients living with autoimmune diseases and contributing to the sustainability of Japan's healthcare system by providing quality-assured, safe and effective biosimilar options,” said Samsung Bioepis Vice President and Head of Commercial Strategy for International Markets, Jinhan Chung.

Ustekinumab is a human immunoglobulin G1 kappa monoclonal antibody designed to prevent abnormal regulation of IL-12 and IL-23 associated with immune-mediated diseases.

Japan’s Pharmaceuticals and Medical Devices Agency granted marketing authorisation for the product in December 2025 for the treatment of plaque psoriasis and psoriatic arthritis.

Samsung Bioepis said it formed a strategic partnership with NIPRO in June 2025 to develop and commercialise multiple biosimilar candidates in Japan, including ustekinumab.

The company added that its ustekinumab biosimilar is already available under different brand names across the European Union, South Korea, the United Kingdom, and the United States.

-- BERNAMA