Ustekinumab is a monoclonal antibody that blocks the inflammatory cytokines interleukin (IL) 12 and IL 23. It is indicated for the treatment of several inflammatory conditions including inflammatory bowel disease (IBD), plaque psoriasis and psoriatic arthritis. It is sold under the brand name Stelara by originator firm Janssen Pharmaceuticals and administered intravenously or subcutaneously.

Patents on Stelara are set to expire in September 2023 in the United States and in January 2024 in most parts of Europe, with a number of biosimilars under development [1].

In July 2021, the South Korean firm Samsung Bioepis began a phase III clinical trial for their ustekinumab biosimilar, SB17. The multicentre, randomized and double-blind trial will evaluate the efficacy, safety, tolerability, pharmacokinetics and immunogenicity of SB17 compared to the originator product (Stelara) in patients with moderate to severe plaque psoriasis. The trial will include over 400 patients across eight countries.

Bio-Thera Solutions (Bio-Thera) have also begun a phase III clinical trial for their proposed biosimilar, currently known as BAT2206. The multicentre, randomized, double-blind trial will compare the efficacy and safety of BAT2206 to Stelara in patients with moderate to severe psoriasis. The first patient has now been dosed in the trial, with a further 471 volunteers expected to enrol.

BAT2206 is Bio-Thera's fourth biosimilar to enter a global phase III clinical study, explained Dr Shengfeng Li, Founder and CEO of Bio-Thera, adding: ‘The advancement of BAT2206 into a global Phase III study demonstrates Bio-Thera’s continued commitment to developing biosimilars of important innovative drugs to expand patient access at lower costs’.

Bio-Thera is also developing a number of other biosimilars, including a golimumab biosimilar, phase III trials for which have recently begun [2]. Golimumab (Simponi) is a monoclonal antibody treatment for inflammatory diseases including IBD, rheumatoid arthritis and psoriatic arthritis. Patents on Simponi will expire in 2024 in both the United States and Europe, creating space in the market for competitors.

Bio-Thera’s biosimilar, BAT2506, is the first subcutaneous golimumab biosimilar to enter phase III trials in a number of countries and could be the first to be approved in China and Europe. The trial includes 598 patients with psoriatic arthritis and is expected to complete in October 2023.

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Biosimilars of ustekinumab

References
1. GaBI Online - Generics and Biosimilars Initiative. Clinical trials begin for ustekinumab biosimilars [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2021 Oct 29]. Available from: www.gabionline.net/biosimilars/research/clinical-trials-begin-for-ustekinumab-biosimilars
2. GaBI Online - Generics and Biosimilars Initiative. Clinical trials begin for Bio-Thera’s golimumab copy biological [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2021 Oct 29]. Available from: www.gabionline.net/biosimilars/research/clinical-trials-begin-for-bio-thera-s-golimumab-copy-biological

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