On 23 December 2025, Samsung Bioepis announced that it has received marketing approval in Japan for Nipro™, biosimilar to J&J’s/Janssen’s Stelara® (ustekinumab). Nipro™ delivers ustekinumab in a subcutaneous 45mg injection, and is the first product to gain marketing approval in Japan under the June 2025 partnership between Samsung Bioepis and Nipro Corporation.
Nipro™ has been approved for the treatment of plaque psoriasis and psoriatic arthritis and is expected to become commercially available following its listing on Japan’s National Health Insurance drug list in May 2026.
Samsung Bioepis’ announcement follows First Word Pharma’s report in September 2025 that Mitsubishi Tanabe Pharma Corporation’s (MTPC) contract with Janssen for co-promotion activities for Janssen’s Stelara® (ustekinumab) in Japan ended on 31 December 2025. Under the co-promotion agreement, MTPC has been responsible for distribution of Stelara® in Japan, with both MTPC and Janssen jointly conducting promotion of Stelara® to healthcare professionals. After 31 December 2025, Janssen exclusively handles the sales, distribution, and information provision activities for Stelara® in Japan, with MTPC continuing the distribution of Stelara® bearing the MTPC name until the inventory is depleted.
Samsung Bioepis is one of a number of biosimilar competitors launching ustekinumab products in Japan, including, Celltrion (July 2025) and Biocon Biologics (May 2025).