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Pivotal clinical trials for bevacizumab biosimilars Posted 18/09/2015

Biosimilars of Roche’s Avastin (bevacizumab), a humanized monoclonal antibody, are currently under development.

Bevacizumab inhibits angiogenesis (the formation of new blood vessels) by blocking the action of vascular endothelial growth factor A (VEGF-A). Bevacizumab can therefore slow the growth of new blood vessels in tumours and is used to treat various cancers, including colorectal, lung, breast, glioblastoma, kidney and ovarian.

Pivotal trials for candidate bevacizumab biosimilars being carried out typically include just one study of the response rate with some progression-free survival data. The trials take 24–48 months and are tougher trials to recruit and execute than anti-TNF trials [1], see Table 1.

Table 1: Pivotal clinical trials for candidate bevacizumab biosimilars

Study ID

Product name

Company name, country

Phase

Trial design

Status

No. of subjects

Start/end dates

Primary outcome(s)

Lung cancer

NCT01966003

ABP 215

Amgen, USA

III

2-arm, parallel

Ongoing

642

Oct 2013/ Sep 2015

ORR

NCT01763645

BCD-021

Biocad, Russia

III

2-arm, parallel

Ongoing

214

Oct 2012/Nov 2015

ORR, AUC

NCT02272413

BI 695502

Boehringer Ingelheim, Germany

III

2-arm, parallel

Recruiting

660

Jul 2015/Mar 2019

ORR

2014-003878-16

PF-06439535

Pfizer, USA

III

2-arm, parallel

Ongoing

798

Feb 2015/-

ORR

AUC: area under the curve; ORR: overall response rate.

The originator product, Roche’s Avastin (bevacizumab), was approved by the US Food and Drug Administration in February 2004 and by the European Medicines Agency in January 2005. The patents on Avastin are set to expire in Europe in January 2022 and in the US in July 2019 [2]. Avastin had worldwide sales of US$7.4 billion in 2014, making it a lucrative target for biosimilars manufacturers.

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References
1. Gal R. Biosimilars: at the inflection point. 13th EGA-European Biosimilars Group Conference; 23–24 April 2015; London, UK.
2. GaBI Online - Generics and Biosimilars Initiative. US$67 billion worth of biosimilar patents expiring before 2020 [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2015 Sep 18]. Available from: www.gabionline.net/Biosimilars/General/US-67-billion-worth-of-biosimilar-patents-expiring-before-2020

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