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Biosimilars of tocilizumab Posted 29/07/2016

Tocilizumab is a humanized monoclonal antibody against the interleukin-6 receptor (IL-6R). It is an immunosuppressive drug used mainly for the treatment of rheumatoid arthritis and systemic juvenile idiopathic arthritis, a severe form of arthritis in children. In Japan, tocilizumab is also approved for the treatment of Castleman’s disease, a rare benign tumour of B cells.

The originator product, Roche’s Actemra/RoActemra (tocilizumab), was approved by the US Food and Drug Administration (FDA) on 8 January 2010 and on 16 January 2009 by the European Medicines Agency (EMA) [1]. Tocilizumab was approved in Japan for Castleman’s disease in June 2005. Actemra/RoActemra had worldwide sales of CHF 1.4 billion (US$1.4 billion) in 2015.

The patents on Actemra/RoActemra expired in the US on 22 December 2015 and will expire in Europe on 23 April 2017 [1]. Some of the tocilizumab biosimilars and non-originator biologicals* approved or in development are presented in Table 1.

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

Company name, Country

Product name

Stage of development

Epirus Biopharmaceuticals, USA

BOW070

Preclinical. Focussed on Castleman’s disease.

*See editor’s comment

On 9 May 2016, Epirus Biopharmaceuticals announced that it was reprioritizing its pipeline to solely focus on biosimilars to treat rare diseases. These include BOW080 (eculizumab biosimilar) and BOW070 (tocilizumab biosimilar). Epirus expects to file for approval of BOW080 in 2020 [2].

Editor’s comment
It should be noted that ‘non-originator biologicals’ approved outside Europe 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 best-selling biologicals. Generics and Biosimilars Initiative Journal (GaBI Journal). 2015;4(4):178-9. doi:10.5639/gabij.2015.0404.040
2. GaBI Online - Generics and Biosimilars Initiative. Epirus expands biosimilars pipeline with Bioceros acquisition [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2016 Jul 29]. Available from: www.gabionline.net/Pharma-News/Epirus-expands-biosimilars-pipeline-with-Bioceros-acquisition

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Source: EMA, Epirus, Roche

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