EC approval for bevacizumab biosimilar Mvasi

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EC approval for bevacizumab biosimilar Mvasi

Biosimilares/Novedades | Posted 02/02/2018 0 Post your comment

Biotech giant Amgen announced on 18 January 2018 that it had received European Commission (EC) approval for its biosimilar bevacizumab product Mvasi (ABP 215).

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 10 November 2017 [1].

Mvasi is the first biosimilar bevacizumab approved by the EC. It has been approved for the treatment of certain types of cancers, including in combination with fluoropyrimidine-based chemotherapy for metastatic carcinoma of the colon or rectum; in combination with paclitaxel for metastatic breast cancer; in combination with platinum-based chemotherapy for unresectable advanced, metastatic or recurrent non-squamous non-small cell lung cancer (NSCLC); in combination with erlotinib for unresectable advanced, metastatic or recurrent non-squamous NSCLC; in combination with interferon alpha-2a for advanced and/or metastatic renal cell cancer; in combination with carboplatin and paclitaxel, carboplatin and gemcitabine, and paclitaxel, topotecan, or pegylated liposomal doxorubicin for advanced, platinum-sensitive, or platinum-resistant recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer; and in combination with paclitaxel and cisplatin, or alternatively, paclitaxel and topotecan for persistent, recurrent, or metastatic carcinoma of the cervix.

The approval was based on a comprehensive data package that demonstrated Mvasi and originator bevacizumab, Roche’s Avastin, are highly similar, with no clinically meaningful differences in terms of the efficacy, safety and immunogenicity between the products. Clinical studies included results from a phase III trial in patients with non-squamous NSCLC.

Mvasi is the first biosimilar to come out of the Amgen/Allergan collaboration. The companies are collaborating on the development and commercialization of four oncology biosimilars.

Mvasi was also approved by the US Food and Drug Administration on 14 September 2017 [2].

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References
1. GaBI Online - Generics and Biosimilars Initiative. EMA approval for bevacizumab biosimilar Mvasi [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2018 Feb 2]. Available from: www.gabionline.net/Biosimilars/News/EMA-approval-for-bevacizumab-biosimilar-Mvasi
2. GaBI Online - Generics and Biosimilars Initiative. FDA approves bevacizumab biosimilar Mvasi [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2018 Feb 2]. Available from: www.gabionline.net/Biosimilars/News/FDA-approves-bevacizumab-biosimilar-Mvasi

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Source: Amgen