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Samsung Bioepis wins approval to sell autoimmune biosimilar in Japan

Published: 23 Dec. 2025, 11:10 Updated: 23 Dec. 2025, 14:13

Samsung Bioepis's headquarters in Songdo is seen in this file photo provided by the company [SAMSUNG BIOEPIS]

Samsung Bioepis, a biosimilar drug developer under Samsung Group, said Tuesday it has received approval to sell its biosimilar treatment for autoimmune disease in Japan.

The biosimilar, which references U.S. biotechnology firm Johnson & Johnson's original drug Stelara, was approved under the product name Ustekinumab BS Subcutaneous Injection 45mg Syringes Nipro, the company said in a press release.

The product will be launched in the Japanese market in May under a partnership with Japanese medical equipment manufacturer Nipro, according to Samsung Bioepis.

The deal marks Samsung Bioepis' first business partnership with a Japanese company to enter Japan's biopharmaceutical market, it said.

"Japan allocates about 10 percent of its gross domestic product to healthcare, one of the highest levels among Organization for Economic Cooperation and Development countries," said Jung Byoung-jin, vice president of Samsung Bioepis. "As a result, biosimilars are playing an increasingly important role in easing the financial burden on the country's healthcare system."

The same biosimilar is marketed as Epyztek in Korea and as Pyzchiva in Europe and the United States.

The global market for Stelara is estimated at 15 trillion won ($10.36 billion), the company said, citing data from Johnson & Johnson.

Yonhap