EMA recommends approval of bevacizumab biosimilar Onbevzi

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EMA recommends approval of bevacizumab biosimilar Onbevzi

Biosimilares/Novedades | Posted 11/12/2020 0 Post your comment

The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) announced on 13 November 2020 that it had recommended granting marketing authorization for the bevacizumab biosimilar Onbevzi.

During the CHMP’s meeting of 9‒12 November 2020, the committee recommended that Onbevzi receive a positive opinion 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.

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 cancers. The originator product, Avastin, is sold by Roche/Genentech.

Onbevzi is produced by Korea-based Samsung Bioepis (Samsung and Biogen’s joint venture). However, this is not the company’s first bevacizumab biosimilar. EMA also recommended granting marketing authorization for the company’s bevacizumab biosimilar, Aybintio, in 2020 [1].

There are already two bevacizumab biosimilars approved in Europe. Mvasi was approved in January 2018 and Zirabev was approved in February 2019 [2]. EMA has also recommended granting marketing authorization for another bevacizumab biosimilar, Equidacent, which is produced by Centus Biotherapeutics, a joint venture between AstraZeneca and Fujifilm Kyowa Kirin Biologics [3].

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References
1. GaBI Online - Generics and Biosimilars Initiative. EMA approves bevacizumab and teriparatide biosimilars [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2020 Dec 11]. Available from: www.gabionline.net/Biosimilars/News/EMA-approves-bevacizumab-and-teriparatide-biosimilars
2. GaBI Online - Generics and Biosimilars Initiative. Biosimilars approved in Europe [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2020 Dec 11]. Available from: www.gabionline.net/Biosimilars/General/Biosimilars-approved-in-Europe
3. GaBI Online - Generics and Biosimilars Initiative. EMA recommends approval of bevacizumab biosimilar Equidacent [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2020 Dec 11]. Available from: www.gabionline.net/Biosimilars/News/EMA-recommends-approval-of-bevacizumab-biosimilar-Equidacent

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Source: EMA