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Biosimilars of ustekinumab Posted 09/04/2021

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.

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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References
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 [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2021 Apr 9]. Available from: www.gabionline.net/Biosimilars/News/Bio-Thera-gains-Chinese-approval-for-adalimumab-copy-biological-and-starts-ustekinumab-trial 
3. GaBI Online - Generics and Biosimilars Initiative. Korean biosimilars makers pipelines and expansion [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2021 Apr 9]. Available from: www.gabionline.net/Pharma-News/Korean-biosimilars-makers-pipelines-and-expansion 
4. GaBI Online - Generics and Biosimilars Initiative. Trials of ustekinumab biosimilars advance [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2020 Apr 9]. Available from: www.gabionline.net/Biosimilars/News/Trials-of-ustekinumab-biosimilars-advance 
5. GaBI Online - Generics and Biosimilars Initiative. Phase I trials started for aflibercept and ustekinumab biosimilars [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2021 Apr 9]. Available from: www.gabionline.net/Biosimilars/News/Phase-I-trials-started-for-aflibercept-and-ustekinumab-biosimilars

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Source: EMA, US FDA

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