The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) announced on 23 July 2020 that it had recommended granting of marketing authorization for the bevacizumab biosimilar Equidacent, which is produced by Centus Biotherapeutics, a joint venture between AstraZeneca and Fujifilm Kyowa Kirin Biologics
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.
EMA adopted a positive opinion for the marketing authorization of Equidacent for the following indications: 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. The drug will be available as a 25 mg/mL concentrate for solution for infusion.
The recommendation was based on data from analytical testing, preclinical and clinical studies demonstrating biosimilarity to the reference product, Avastin. This included a phase III clinical trial which showed no clinically meaningful differences in terms of safety, efficacy or immunogenicity to Avastin in patients with non-small cell lung cancer.
Commenting on the news, Centus President and Product Development Team Lead Dr Hiroshi Ohashi said: ‘We are very happy receiving a positive CHMP [Committee for Medicinal Products for Human Use] opinion toward approval of Equidacent, our bevacizumab biosimilar. We will continue with every effort to bring Equidacent to patients and healthcare professionals’.
The European Commission is expected to give final approval to Equidacent in September 2020, allowing Centus to begin selling the product in the European Union, as well as the UK and European Economic Area Member States.
EMA recently recommended granting marketing authorization for a further bevacizumab biosimilar, Aybintio, which is produced by Korea-based Samsung Bioepis [1].
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Reference
1. GaBI Online - Generics and Biosimilars Initiative. EMA approves bevacizumab and teriparatide biosimilars [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2020 Aug 28]. Available from: www.gabionline.net/Biosimilars/News/EMA-approves-bevacizumab-and-teriparatide-biosimilars
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Source: Centus Biotherapeutics, EMA
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