FDA accepts application for bevacizumab biosimilar

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FDA accepts application for bevacizumab biosimilar

Biosimilars/News | Posted 25/11/2016 0 Post your comment

Biotech giant Amgen and its partner Allergan, announced on 15 November 2016 that the regulatory submission for its proposed bevacizumab biosimilar (ABP 215) had been accepted for review by the US Food and Drug Administration (FDA). The companies believe this submission is the first bevacizumab biosimilar application submitted to FDA.

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 FDA submission was based on analytical, pharmacokinetic and clinical data, as well as pharmacology and toxicology data. The data submitted by the two companies also contains results from their phase III comparative efficacy, safety and immunogenicity study, which was conducted in adult patients with non-squamous non-small cell lung cancer. The phase III study, according to Amgen and Allergan, ‘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. 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 [1]. Allergan is also independently developing biosimilars.

Biosimilars approved in the US

Reference
1. GaBI Online - Generics and Biosimilars Initiative. FDA approval for Amgen’s adalimumab biosimilar [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2016 Nov 25]. Available from: www.gabionline.net/Biosimilars/News/FDA-approval-for-Amgen-s-adalimumab-biosimilar

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Source: Source: Amgen