On 18 August 2022, South Korea-based biologicals specialist Celltrion announced that its bevacizumab biosimilar, Vegzelma (CT-P16), had received European Commission (EC) approval.
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 originator product, Avastin, is sold by Roche/Genentech [1].
The European Commission (EC) has approved Vegzelma for the treatment of 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.
The EC approval follows a positive opinion issued in June 2022 by the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) and is applicable to all 27 European Union Member States plus Iceland, Norway and Liechtenstein [2].
The positive CHMP opinion was supported by a comprehensive data package, including a phase III clinical trial in patients with metastatic or recurrent non-squamous non-small cell lung cancer, and the totality of evidence demonstrates biosimilarity to Avastin for all indications.
This bevacizumab biosimilar is Celltrion’s third oncology biosimilar approved by the EC. The company has also applied for marketing approval for this bevacizumab biosimilar (CT-P16) in Korea and the US [3].
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References
1. GaBI Online - Generics and Biosimilars Initiative. Biosimilars of bevacizumab [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2022 Sep 23]. Available from: www.gabionline.net/biosimilars/general/Biosimilars-of-bevacizumab
2. GaBI Online - Generics and Biosimilars Initiative. EMA recommends approval of bevacizumab biosimilar vegzelma [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2022 Sep 23]. Available from: www.gabionline.net/biosimilars/news/ema-recommends-approval-of-bevacizumab-biosimilar-vegzelma
3. 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 Sep 23]. Available from: www.gabionline.net/biosimilars/news/celltrion-seeks-approval-for-bevacizumab-biosimilar-in-europe-us-and-korea
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