Biosimilars of certolizumab pegol Posted 21/04/2017

Certolizumab pegol is a monoclonal antibody directed against tumour necrosis factor-alfa (TNF-α). More precisely, it is a PEGylated Fab’ fragment of a humanized TNF inhibitor monoclonal antibody. It is indicated for the treatment of Crohn’s disease, rheumatoid arthritis, psoriatic arthritis and ankylosing spondylitis.

The originator product, UCB’s Cimzia (certolizumab pegol), was approved by the US Food and Drug Administration (FDA) in April 2008 and by the European Medicines Agency (EMA) in October 2009 [1]. Cimzia had sales of US$1.1 billion in 2015.

The patents on Cimzia will expire in Europe in 2021 and in the US in 2024 [1]. Some of the certolizumab pegol biosimilars and non-originator biologicals* approved or in development are presented in Table 1.

Table 1: Biosimilars and non-originator biologicals* of certolizumab pegol in development

Company name, Country

Product name

Stage of development

PFEnex, USA

PF688

Biosimillar candidate undergoing preclinical/ bioanalytical characterization

*See editor’s comment.

Editor’s comment
It should be noted that ‘non-originator biologicals’ approved in less regulated countries 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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Reference
1. Derbyshire M. Patent expiry dates for biologicals: 2016 update. Generics and Biosimilars Initiative Journal (GaBI Journal). 2017;6(1):27-30. doi:10.5639/gabij.2017.0601.006

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Source: ClinicalTrials.gov, EMA, US FDA

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