Biosimilars of ustekinumab

Biosimilares/General | Posted 09/04/2021 post-comment0 Post your comment

Ustekinumab is a humanized monoclonal antibody that interferes with the triggering of the body’s inflammatory response through the suppression of certain cytokines. Specifically, it blocks interleukin IL 12 and IL 23 which help activate certain T cells. It binds to the p 40 subunit of both IL 12 and IL 23 so that they subsequently cannot bind to their receptors. It is indicated for the treatment of Crohn’s disease, psoriasis and psoriatic arthritis.

Ustekinumab MOA V21F04

The originator product, Johnson & Johnson’s Stelara (ustekinumab), was approved by the US Food and Drug Administration (FDA) on 25 September 2009 and by the European Medicines Agency (EMA) on 16 January 2009 [1]. Stelara had worldwide net sales of US$6.4 billion in 2019, making it a lucrative target for biosimilars developers.

The patents on Stelara will expire in the US in September 2023 and in Europe in January 2024 [1]. Some of the ustekinumab biosimilars and non-originator biologicals* approved or in development are presented in Table 1.

Table 1: Biosimilars and non-originator biologicals* of ustekinumab approved or in development
Company name, Country Product name Stage of development
Bio-Thera Solutions, China* BAT2206 Phase I [2]
Celltrion Healthcare CT-P43 Phase III trial started in January 2021 [3]
Dong-A/Meiji Seika Pharma, Korea/Japan DMB-3115 Phase I trial started in December 2019 [4]
Epirus Biopharmaceuticals/Bioceros Holding, USA/The Netherlands BOW090 Pre-clinical. Epirus expected to file for approval of BOW090 in 2021. Company filed for bankruptcy in July 2016.
Formycon/Aristo Pharma, Germany FYB202 Phase I trial started in October 2019 [5]
NeuClone/Serum Institute of India, Australia/India* NeuLara Phase I trial completed in April 2020 and early analysis of data suggests is safe and tolerable [4]
*See editor’s comment.

Editor’s comment
European Medicines Agency regulatory requirements ensure the same high standards of quality, safety and efficacy for biosimilars as for originator biologicals, and also include a rigorous comparability exercise with the reference product but they are not universally accepted by regulatory bodies outside of the European Union (EU). It should be noted that ‘copy biologicals’ approved in China and ‘similar biologics’ approved in India might not have been authorized if they had been subjected to the strict regulatory processes required for approval of biosimilars in the EU.

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To further enhance the objectives of GaBI in sharing information and knowledge that ensure policies supportive of safe biosimilars use, we are pleased to announce that we will be launching a new section on GaBI Online and GaBI Journal, the ‘Latin American Forum’ (in Spanish) featuring the latest news and updates on research and developments in generic and biosimilar medicines in Latin America.

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Para fomentar los objetivos de GaBI sobre la difusión de información y conocimiento sobre las políticas de apoyo que garantizan el uso seguro de medicamentos biosimilares, nos complace anunciar el lanzamiento de una nueva sección en GaBI Online y GaBI Journal, el ‘Latin American Forum’ (en español), que presentará las últimas noticias y actualizaciones en investigación y desarrollo sobre medicamentos genéricos y biosimilares en Latinoamérica.

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1. Derbyshire M. Patent expiry dates for biologicals: 2018 update. Generics and Biosimilars Initiative Journal (GaBI Journal). 2019;8(1):24-31. doi:10.5639/gabij.2019.0801.003
2. GaBI Online - Generics and Biosimilars Initiative. Bio-Thera gains Chinese approval for adalimumab copy biological and starts ustekinumab trial []. Mol, Belgium: Pro Pharma Communications International; [cited 2021 Apr 9]. Available from: 
3. GaBI Online - Generics and Biosimilars Initiative. Korean biosimilars makers pipelines and expansion []. Mol, Belgium: Pro Pharma Communications International; [cited 2021 Apr 9]. Available from: 
4. GaBI Online - Generics and Biosimilars Initiative. Trials of ustekinumab biosimilars advance []. Mol, Belgium: Pro Pharma Communications International; [cited 2020 Apr 9]. Available from: 
5. GaBI Online - Generics and Biosimilars Initiative. Phase I trials started for aflibercept and ustekinumab biosimilars []. Mol, Belgium: Pro Pharma Communications International; [cited 2021 Apr 9]. Available from:

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Source: EMA, US FDA

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