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EC approval for bevacizumab biosimilar Zirabev Posted 08/03/2019

US-based drugmaker pharma giant Pfizer announced on 19 February 2019 that it had received European Commission (EC) approval for its bevacizumab biosimilar Zirabev (PF 06439535).

Bevacizumab is a humanized monoclonal antibody. It 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.

The approval by the EC follows the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) positive recommendation on 13 December 2018 [1]. which was based on a comprehensive submission package demonstrating biosimilarity of Zirabev and the originator product, Roche’s Avastin (bevacizumab). This included results from the phase III REFLECTIONS B739 03 clinical comparative study, which showed clinical equivalence and found no clinically meaningful differences between Zirabev and Avastin in patients with advanced non-squamous non-small-cell lung carcinoma (NSCLC) [2]. As part of the overall REFLECTIONS clinical trial programme, Zirabev has been studied in approximately 400 subjects.

With the approval of Zirabev, Pfizer (via its Hospira subsidiary) now has five biosimilars approved for use in Europe. Retacrit (epoetin zeta) was approved in December 2007, Nivestim (filgrastim) was approved in June 2010, Inflectra (infliximab) was approved in September 2013 and Trazimera (trastuzumab) was approved in July 2018 [3]. Pfizer also says that it has ‘a robust portfolio of potential biosimilar candidates in mid- to late-stage development’.

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References
1. GaBI Online - Generics and Biosimilars Initiative. EMA approval for bevacizumab biosimilar Zirabev [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2019 Mar 8]. Available from: www.gabionline.net/Biosimilars/News/EMA-approval-for-bevacizumab-biosimilar-Zirabev 
2. GaBI Online - Generics and Biosimilars Initiative. Comparison of biosimilar and originator bevacizumab in NSCLC [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2019 Mar 8]. Available from: www.gabionline.net/Biosimilars/Research/Comparison-of-biosimilar-and-originator-bevacizumab-in-NSCLC 
3. GaBI Online - Generics and Biosimilars Initiative. Biosimilars approved in Europe [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2019 Mar 8]. Available from: www.gabionline.net/Biosimilars/General/Biosimilars-approved-in-Europe 

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Source: Pfizer

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