Earlier in mid-2025, South Korea’s Samsung Bioepis and Japan’s NIPRO had entered a biosimilars partnership [1]. Samsung Bioepis handles the development, manufacturing, and supply, while NIPRO oversees commercialization in Japan.

Ustekinumab is a humanized monoclonal antibody that interferes with the triggering of the body’s inflammatory response through the suppression of certain cytokines. It is indicated for the treatment of Crohn’s disease, psoriasis and psoriatic arthritis [2]. The originator is Johnson & Johnson’s Stelara.

In Japan, ‘NIPRO’ has now been approved for the treatment of plaque psoriasis and psoriatic arthritis. The product is set to be listed in Japan’s National Health Insurance (NHI) drug list in May 2026, which will enableits commercialization. Samsung Bioepis’ ustekinumab biosimilar has already been approved and is available in Australia, Brazil, Canada, Europe, Korea, Switzerland, the United Kingdom, and the United States [3].

Related articles
EC approval of first ustekinumab biosimilar Uzpruvo

FDA approves first interchangeable ustekinumab biosimilar Wezlana

References
1. GaBI Online - Generics and Biosimilars Initiative. Global partnerships for biosimilar commercialization announced [www.gabionline.net].Mol, Belgium: Pro Pharma Communications International; [cited 2026 May 6]. Available from: www.gabionline.net/pharma-news/global-partnerships-for-biosimilar-commercialization-announced
2. GaBI Online - Generics and Biosimilars Initiative. Biosimilars of ustekinumab [www.gabionline.net].Mol, Belgium: Pro Pharma Communications International; [cited 2026 May 6]. Available from: www.gabionline.net/biosimilars/general/biosimilars-of-ustekinumab
3. GaBI Online - Generics and Biosimilars Initiative. The ustekinumab shift: biosimilars displace Stelara’s market leadership [www.gabionline.net].Mol, Belgium: Pro Pharma Communications International; [cited 2026 May 6]. Available from: www.gabionline.net/biosimilars/general/the-ustekinumab-shift-biosimilars-displace-stelara-s-market-leadership

Permission granted to reproduce for personal and non-commercial use only. All other reproduction, copy or reprinting of all or part of any ‘Content’ found on this website is strictly prohibited without the prior consent of the publisher. Contact the publisher to obtain permission before redistributing.

Copyright – Unless otherwise stated all contents of this website are © 2026 Pro Pharma Communications International. All Rights Reserved.