Biosimilars of cetuximab

Biosimilars/General | Posted 14/08/2014 post-comment0 Post your comment

Last Update: 13 April 2018

Cetuximab is a chimeric (mouse/human) monoclonal antibody. It inhibits epidermal growth factor receptor (EGFR) and is used to treat metastatic colorectal cancer, metastatic non-small cell lung cancer and head and neck cancer.

Cetuximab V14h14

The originator product, Eli Lilly/Merck Group’s Erbitux (cetuximab), was approved by the US Food and Drug Administration (FDA) in February 2004 and by the European Medicines Agency (EMA) in June 2004 [1]. Erbitux had 2016 worldwide sales of US$1.7 billion (US$1.05 billion [Euros 880 million] Merck Group + US$687 million Eli Lilly [ImClone subsidiary]), making it a lucrative target for biosimilars developers, see Table 1.

The patents on Erbitux expired in the US in February 2016 and in Europe in June 2014 [1]. Just some of the cetuximab biosimilars and non-originator biologicals* approved or in development are presented in Table 1.

Table 1: Biosimilars and non-originator biologicals* of cetuximab approved or in development

Company name, Country Product name Stage of development
Actavis/Amgen, USA ABP 494 Developing a biosimilar in collaboration [2]
BioXpress Therapeutics, Switzerland - In pipeline
Celltrion, South Korea CT-P15 In pipeline
CinnaGen, Iran* - Phase III study in metastatic colorectal cancer patients expected to be completed November 2018 [3]
MabTech/Sorrento Therapeutics, China*/USA STI-001 Positive phase III results for copy biological in China reported in January 2016 [4]
Oncobiologics/Viropro, USA - One of six monoclonal antibody biosimilars for which the companies are collaborating [5]
*See editor’s comment

Despite the fact that the European patent on Erbitux expired in June 2014, there is only a Chinese ‘copy biological’ in late-stage development. This makes it unlikely that there will be any biosimilar competitors to Erbitux in Europe in the near future.

Editor’s comment
It should be noted that ‘copy biologicals’ approved in China and ‘biogenerics’ approved in Iran might not have been authorized following as strict a regulatory process as is required for approval of biosimilars in the European Union. The EMA (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.

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References
1. Derbyshire M. Patent expiry dates for biologicals: 2017 update. Generics and Biosimilars Initiative Journal (GaBI Journal). 2018;7(1):29-34. doi:10.5639/gabij.2018.0701.007
2. GaBI Online - Generics and Biosimilars Initiative. Amgen’s biosimilar plans [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2014 Aug 14]. Available from: www.gabionline.net/Biosimilars/News/Amgen-s-biosimilar-plans
3.  GaBI Online - Generics and Biosimilars Initiative. MENA region biologicals maker CinnaGen received EU GMP certification [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2018 Apr 13]. Available from: www.gabionline.net/Pharma-News/MENA-region-biologicals-maker-CinnaGen-received-EU-GMP-certification
4. GaBI Online - Generics and Biosimilars Initiative. Positive phase III results for cetuximab and rituximab copy biologicals [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2016 Apr 1]. Available from: www.gabionline.net/Biosimilars/Research/Positive-phase-III-results-for-cetuximab-and-infliximab-copy-biologicals
5. GaBI Online - Generics and Biosimilars Initiative. Oncobiologics and Viropro make biosimilar deal [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2014 Aug 14]. Available from: www.gabionline.net/Biosimilars/News/Oncobiologics-and-Viropro-make-biosimilar-deal

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Source: US FDA

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