Pivotal clinical trials for bevacizumab biosimilars

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

Bevacizumab 2 V14f01

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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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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