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Biosimilars of eculizumab Posted 10/06/2016

Last update: 20 October 2017

Eculizumab is a humanized monoclonal antibody that is a terminal complement inhibitor. It is used to treat people with paroxysmal nocturnal haemoglobinuria (PNH), for whom it improves quality of life but does not appear to affect the risk of death. It is also indicated for the treatment of patients with atypical haemolytic uremic syndrome (aHUS) – a disease that primarily affects kidney function – to inhibit complement-mediated thrombotic microangiopathy.

The originator product, Soliris (eculizumab), made by Alexion Pharmaceuticals, was approved by the US Food and Drug Administration (FDA) on 16 March 2007 for the treatment of PNH and on 23 September 2011 for the treatment of aHUS. It was approved by the European Medicines Agency (EMA) for the treatment of PNH on 20 June 2007 and on 24 November 2011 for the treatment of aHUS [1]. Soliris had worldwide net sales of US$2.6 billion in 2015, making it a lucrative target for biosimilars developers, see Table 1.

The patents on Soliris will expire in the US on 16 March 2021 and in Europe on 1 May 2020 [1]. Some of the eculizumab biosimilars and non-originator biologicals* approved or in development are presented in Table 1.

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

Company name, Country

Product name

Stage of development

Actavis/Amgen, USA

ABP 959

Developing a biosimilar in collaboration [2]

Epirus Biopharmaceuticals, USA

BOW080

Preclinical. Epirus expects to file for approval of BOW080 in 2020 [3]

*See editor’s comment

On 9 May 2016, Epirus Biopharmaceuticals announced that it was re-prioritizing its pipeline to solely focus on biosimilars to treat rare diseases. These include BOW080 (eculizumab biosimilar) and BOW070 (tocilizumab biosimilar).

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 biologicals: 2016 update. Generics and Biosimilars Initiative Journal (GaBI Journal). 2017;6(1):27-30. doi:10.5639/gabij.2017.0601.006
2. GaBI Online - Generics and Biosimilars Initiative. Amgen’s biosimilar plans [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2017 Oct 20]. Available from: www.gabionline.net/Biosimilars/News/Amgen-s-biosimilar-plans
3. GaBI Online - Generics and Biosimilars Initiative. Epirus expands biosimilars pipeline with Bioceros acquisition [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2016 May 19]. Available from: www.gabionline.net/Pharma-News/Epirus-expands-biosimilars-pipeline-with-Bioceros-acquisition

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Source: Alexion Pharma, EMA, Epirus

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