Bevacizumab biosimilar application submitted to EMA

Biosimilares/Novedades | Posted 09/12/2016 post-comment0 Post your comment

Biotech giant Amgen and its partner Allergan announced on 2 December 2016 that they had submitted their application for approval for their proposed bevacizumab biosimilar (ABP 215) to the European Medicines Agency (EMA). The companies believe this submission is the first bevacizumab biosimilar application submitted to EMA.

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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 product is a proposed biosimilar to Roche’s Avastin (bevacizumab), which had worldwide sales of CHF 6.7 billion (US$6.9 billion) in 2015. The patents on Avastin will expire in the US in July 2019 and in Europe in January 2022 [1].

The EMA submission includes analytical, pharmacokinetic and clinical data, as well as pharmacology and toxicology data. The phase III comparative efficacy, safety and immunogenicity study was conducted in adult patients with non-squamous non-small cell lung cancer (NSCLC). According to Amgen, ‘the phase III study confirmed no clinically meaningful difference to bevacizumab in terms of efficacy, safety and immunogenicity’.

Amgen and Allergan are collaborating on four oncology biosimilars and say that the bevacizumab biosimilar (ABP 215) is the most advanced. The companies also submitted their bevacizumab biosimilar for approval to the US Food and Drug Administration (FDA) in November 2016 [1]. Amgen has a total of nine biosimilars in its portfolio, eight of which are in ongoing development. It gained approval for its adalimumab biosimilar, Amjevita (adalimumab-atto), from FDA in September 2016 [2]. Allergan is also independently developing biosimilars.

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1. GaBI Online - Generics and Biosimilars Initiative. FDA accepts application for bevacizumab biosimilar []. Mol, Belgium: Pro Pharma Communications International; [cited 2016 Dec 9]. Available from: 
2. GaBI Online - Generics and Biosimilars Initiative. FDA approval for Amgen’s adalimumab biosimilar []. Mol, Belgium: Pro Pharma Communications International; [cited 2016 Dec 9]. Available from:

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Source: Amgen

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