EMA approval for bevacizumab biosimilar Mvasi

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EMA approval for bevacizumab biosimilar Mvasi

Biosimilars/News | Posted 24/11/2017 0 Post your comment

The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) announced on 10 November 2017 that it had recommended granting marketing authorization for the bevacizumab biosimilar Mvasi.

The bevacizumab biosimilar, Mvasi, is produced by biotech giant Amgen and partner Allergan. The pair submitted their application for their bevacizumab biosimilar (ABP 215) to EMA in December 2016 [1].

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 [2].

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 Mvasi be approved for the treatment of carcinoma of the colon or rectum, breast cancer, non-small cell lung cancer, renal cell cancer, epithelial ovarian, fallopian tube or primary peritoneal cancer and carcinoma of the cervix.

The positive opinions will now be referred to the European Commission (EC), which grants marketing authorizations for medicines in the European Union.

The US Food and Drug Administration also approved Mvasi (bevacizumab-awwb) in September 2017 [2].

Amgen and Allergan are collaborating on the development and commercialization of four oncology biosimilars. Amgen has a total of 10 biosimilars in its portfolio, one of which Amgevita (adalimumab) was approved by the EC in March 2017 [3].

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References
1. GaBI Online - Generics and Biosimilars Initiative. Bevacizumab biosimilar application submitted to EMA [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2017 Nov 24]. Available from: www.gabionline.net/Biosimilars/News/Bevacizumab-biosimilar-application-submitted-to-EMA
2. GaBI Online - Generics and Biosimilars Initiative. FDA approves bevacizumab biosimilar Mvasi [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2017 Nov 24]. Available from: www.gabionline.net/Biosimilars/News/FDA-approves-bevacizumab-biosimilar-Mvasi
3. GaBI Online - Generics and Biosimilars Initiative. EC approval for adalimumab biosimilar Amgevita [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2017 Nov 24]. Available from: www.gabionline.net/Biosimilars/News/EC-approval-for-adalimumab-biosimilar-Amgevita

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Source: Amgen, EMA