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EC approval for bevacizumab biosimilar Equidacent Posted 16/10/2020

Centus Biotherapeutics Ltd announced on 29 September 2020 that the European Commission (EC) granted marketing authorization for Equidacent, its Avastin (bevacizumab) biosimilar.

The EC approval follows the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) July recommendation to grant marketing authorization for Equidacent [1] and applies to 27 European Union (EU) Member States, the UK and the European Economic Area (EEA) Member States of Norway, Iceland and Liechtenstein.

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.

Equidacent will now be available as a 25 mg/mL concentrate for solution for infusion. The product is indicated for several indications. These are: metastatic carcinoma of the colon or rectum; metastatic breast cancer; unresectable advanced, metastatic, or recurrent non-small cell lung cancer; advanced and/or metastatic renal cell cancer; epithelial ovarian, fallopian tube, or primary peritoneal cancer; and persistent, recurrent, or metastatic carcinoma of the cervix.

Centus is a joint venture between AstraZeneca and Fujifilm Kyowa Kirin Biologics that began in 2015. In a statement, Fujifilm Kyowa Kirin Biologics President and CEO Atsushi Matsumoto noted that the company is proud to receive EC approval and that this demonstrates the successful utilization of its deep scientific expertise to develop biosimilars in collaboration with AstraZeneca.

Equidacent is soon likely to be joined on the EC market by another bevacizumab biosimilar, Aybintio, which is produced by Samsung Bioepis. This product received CHMP recommendation to grant marketing authorization in June 2020 and has since reported positive results from a phase III trial [2].

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References
1. GaBI Online - Generics and Biosimilars Initiative. EMA recommends approval of bevacizumab biosimilar Equidacent [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2020 Oct 16]. Available from: www.gabionline.net/Biosimilars/News/EMA-recommends-approval-of-bevacizumab-biosimilar-Equidacent
2. GaBI Online - Generics and Biosimilars Initiative. Phase III trial updates of Samsung Bioepis bevacizumab and aflibercept biosimilars [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2020 Oct 16]. Available from: www.gabionline.net/Biosimilars/Research/Phase-III-trial-updates-of-Samsung-Bioepis-bevacizumab-and-aflibercept-biosimilars

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