Samsung Bioepis Secures Marketing Authorization for Autoimmune Disease Treatment in Japan

Obtains Approval for Stelara Biosimilar from MHLW; Launch Set for May 2026 via Local Partner 'Nipro'

[Han Kwangbeom, Edaily Reporter] Samsung Bioepis has received marketing authorization from Japan’s Ministry of Health, Labour and Welfare (MHLW) for SB17 (ingredient name: ustekinumab), its biosimilar referencing the autoimmune disease treatment Stelara.

Samsung Bioepis.

Stelara is a block-buster biologic that inhibits the activity of interleukin (IL)-12 and 23, which are signaling molecules involved in immune responses. It is indicated for conditions such as plaque psoriasis, psoriatic arthritis, and ulcerative colitis. The drug's annual global sales reach approximately $10.36 billion (around 15 trillion KRW).

Samsung Bioepis plans to launch the Stelara biosimilar in Japan in May next year through its local commercial partner, Nipro Corporation. The two companies signed a partnership agreement for the product's commercialization in Japan last June, marking Samsung Bioepis' first collaboration with a local firm to enter the Japanese market.

"Through this marketing authorization, we are able to improve treatment access for patients with autoimmune diseases in Japan and establish a significant foothold for expanding our global market presence as a leader in the biosimilar industry," said Byoungin Jung, Vice President and Regulatory Affairs (RA) Team Lead at Samsung Bioepis.

From July 2021 to November 2022, Samsung Bioepis conducted a global Phase 3 clinical trial of SB17 involving 503 patients with plaque psoriasis across eight countries. The study confirmed clinical equivalence in terms of efficacy and safety compared to the original reference product.

Samsung Bioepis has already launched the Stelara biosimilar under the brand name Pyzchiva® in Europe and the U.S. through its marketing partner Sandoz, while it is being sold directly in South Korea under the name Epyztek®.

한광범 (totoro@edaily.co.kr)