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EMA approval for bevacizumab biosimilar Zirabev Posted 11/01/2019

The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) announced on 13 December 2018 that it had recommended granting marketing authorization for the bevacizumab biosimilar Zirabev.

Zirabev (PF‑06439535) is produced by pharma giant Pfizer. The product is a proposed biosimilar to Roche’s Avastin (bevacizumab), which had worldwide sales of CHF 6.8 billion (Euros 5.95 billion) in 2016, before biosimilars competition. The patents on Avastin will expire in the US in July 2019 and in Europe in January 2022 [1].

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 CHMP has recommended that Zirabev be approved for the treatment of carcinoma of the colon or rectum, breast cancer, non-small cell lung cancer, renal cell cancer and carcinoma of the cervix.

The positive opinion was given based on a comprehensive data package and evidence demonstrating biosimilarity to the originator product. This includes results from the phase III REFLECTIONS B739‑03 clinical comparative study, which demonstrated clinical equivalence and found no clinically meaningful differences between Zirabev and Avastin in patients with advanced non-squamous non-small cell lung cancer (NSCLC) [1]. As part of the overall REFLECTIONS clinical trial programme, Zirabev has been studied in approximately 400 subjects.

This recommendation marks the second bevacizumab biosimilar to be approved in Europe. Mvasi was the first bevacizumab biosimilar to be approved by the Europe Commission (EC) in January 2018 [2].

The positive opinion for Zirabev will be referred to the EC, which grants marketing authorizations for medicines in the European Union.

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1. 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 Jan 11]. Available from: www.gabionline.net/Biosimilars/Research/Comparison-of-biosimilar-and-originator-bevacizumab-in-NSCLC
2. GaBI Online - Generics and Biosimilars Initiative. EC approval for bevacizumab biosimilar Mvasi [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2019 Jan 11]. Available from: www.gabionline.net/Biosimilars/News/EC-approval-for-bevacizumab-biosimilar-Mvasi

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Source: EMA, Pfizer

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