EMA recommends approval of bevacizumab biosimilar Vegzelma

Biosimilars/News | Posted 01/07/2022 post-comment0 Post your comment

The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) announced on 24 June 2022 that it had recommended granting marketing authorization for the bevacizumab biosimilar Vegzelma.

Bevacizumab 1 V14f01

During the CHMP’s meeting of 20–23 June 2022, the committee recommended that Vegzelma receives 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-alpha (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.

Vegzelma (CT-P16) is produced by South Korean biotechnology company Celltrion. The company has already received approval for five other biosimilars in Europe [1]. Once approved, Vegzelma will be Celltrion’s third therapeutic oncology biosimilar. This says Kevin Byoung Seo Choi, Senior Vice President and Head of Marketing Division at Celltrion Healthcare, shows the company’s ‘ongoing commitment to bringing high quality and innovative biosimilars to the market, providing additional treatment options for people living with cancers’.

The positive CHMP opinion was supported by a comprehensive data package and totality of evidence demonstrating biosimilarity to the reference product (Avastin) for indications including metastatic breast cancer, non-small cell lung cancer, advanced and/or metastatic renal cell cancer, metastatic carcinoma of the colon or rectum, ovarian cancer and cervical cancer.

There are already eight bevacizumab biosimilars approved in Europe [1]. Celltrion has also applied for marketing approval for its bevacizumab biosimilar (CT-P16) in Korea and the US [2].

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1. GaBI Online - Generics and Biosimilars Initiative. Biosimilars approved in Europe [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2022 Jul 1]. Available from: www.gabionline.net/biosimilars/general/biosimilars-approved-in-europe
2. GaBI Online - Generics and Biosimilars Initiative. Celltrion seeks approval for bevacizumab biosimilar in Europe, US and Korea [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2022 Jul 1]. Available from: www.gabionline.net/biosimilars/news/celltrion-seeks-approval-for-bevacizumab-biosimilar-in-europe-us-and-korea

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Source: Celltrion, EMA

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