Nam Hyun-woo has worked as a staff writer at The Korea Times since 2013, mostly covering business and politics. He currently belongs to the Business Desk where he covers topics such as emerging tech, AI, ICT and Korea's chaebol community. Prior to joining the team, he was the paper's correspondent for the presidential office of Korea during the Yoon Suk Yeol and Moon Jae-in administrations.
Samsung Bioepis launches Ustekinumab biosimilar in Japan with Nipro
Samsung Bioepis headquarters in Incheon / Courtesy of Samsung Bioepis
By Nam Hyun-woo
Samsung Bioepis announced Wednesday the launch of its Ustekinumab biosimilar in Japan, marking the company’s first product debut in the country under a partnership with NIPRO Corp.
The product, Ustekinumab BS 45 mg Syringe for S.C. Injection “NIPRO,” was listed under Japan’s National Health Insurance (NHI) drug price standard following an Official Gazette announcement on Tuesday, becoming effective the same day.
The launch represents Samsung Bioepis’ entry into the Japanese biosimilars market through its collaboration with Nipro.
“We are thrilled to announce the launch of our first biosimilar product in Japan in partnership with Nipro,” said Chung Jin-han, vice president and head of commercial strategy for international markets at Samsung Bioepis.
“Together with our partner, we look forward to supporting patients living with autoimmune diseases and contributing to the sustainability of Japan’s health care system by providing quality-assured, safe and effective biosimilar options.”
Ustekinumab is a human immunoglobulin G1 kappa monoclonal antibody designed to inhibit the abnormal regulation of interleukin-12 and interleukin-23, which are linked to immune-mediated diseases.
Japan’s drug regulator, the Pharmaceuticals and Medical Devices Agency, granted marketing authorization for the biosimilar in December 2025 for the treatment of plaque psoriasis and psoriatic arthritis.
Samsung Bioepis and Nipro signed a strategic partnership in June last year to develop and commercialize multiple biosimilar candidates in Japan, including ustekinumab.
The company noted that its ustekinumab biosimilar is already marketed under different brand names in the European Union, Korea, the United Kingdom and the United States.