Samsung Bioepis has launched its first biosimilar product in Japan, aiming to improve treatment access for patients with autoimmune diseases and expand its global footprint. The company announced on the 20th that it has introduced 'SB17' (ingredient: ustekinumab) in Japan through its local marketing partner, Nipro Corporation. SB17 is a biosimilar of Johnson & Johnson's 'Stelara', primarily indicated for plaque psoriasis and psoriatic arthritis.
The product launch followed rapid regulatory approval and drug price listing. Samsung Bioepis received marketing authorization from Japan's Ministry of Health, Labour and Welfare in December last year. On the 19th, the product was listed under Japan's National Health Insurance (NHI) drug pricing system, and sales commenced the following day. The approved product name in Japan is 'Ustekinumab BS 45mg Subcutaneous Injection Nipro'.
With this launch, Samsung Bioepis plans to fully enter the Japanese market. The company signed a strategic partnership with Nipro in June last year to commercialize multiple biosimilars, including the Stelara biosimilar, in Japan.
Samsung Bioepis continues to expand its ustekinumab biosimilar supply in key global markets. It is currently sold under the brand name 'Pyzchiva' in Europe and the United States, and 'Epiztek' in South Korea. Jeong Jin-han, Commercial Business Unit Executive Director at Samsung Bioepis, stated, "By providing high-quality biosimilar treatment options to Japanese patients with autoimmune diseases, we aim to improve treatment accessibility."
Japan's ustekinumab market opened first for psoriasis indications. The original drug Stelara (ustekinumab) is an injectable that inhibits the activity of interleukin (IL)-12 and IL-23, proteins secreted by immune cells. In autoimmune disease patients, these proteins are overproduced, causing the immune system to mistakenly attack normal cells or skin tissue, leading to chronic inflammation and pain. Ustekinumab works by selectively blocking these two proteins, calming the excessive immune response and alleviating disease symptoms.
The opening of Japan's Stelara biosimilar market has been phased, based on regulatory conditions and patent status. Stelara's main indications include plaque psoriasis, psoriatic arthritis, Crohn's disease, and ulcerative colitis. However, the re-examination period after Stelara's approval in Japan varied by indication. The re-examination period for plaque psoriasis and psoriatic arthritis ended on January 20, 2019. For Crohn's disease and ulcerative colitis, the period was extended to May 31, 2025, due to pediatric clinical needs.
This explains why subcutaneous injection biosimilars for plaque psoriasis and psoriatic arthritis have appeared first in Japan. The first Stelara biosimilar in Japan was Fuji Pharmaceutical Industry's 'Ustekinumab BS 45mg Syringe F', listed in May 2024. In May 2025, Yosindo's 'YD' product and Celltrion Healthcare Japan's 'CT' product were simultaneously listed. Samsung Bioepis's 'Ustekinumab BS 45mg Subcutaneous Injection Nipro' is also initially indicated for plaque psoriasis and psoriatic arthritis.
Source: Read the original report | Published: May 20, 2026