On September 29, 2020 Centus Biotherapeutics Ltd., a joint venture between Fujifilm Kyowa Kirin Biologics Co., Ltd. and AstraZeneca, reported that the European Commission (EC) has granted the marketing authorization for Equidacent (Product Code: FKB238), the company’s biosimilar to Avastin (bevacizumab) (Press release, Kyowa Hakko Kirin, SEP 29, 2020, View Source [SID1234567718]).
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The authorization follows the adoption of a positive opinion by the Committee for Medicinal Products for Human Use (CHMP), which concluded that the development program including analytical, functional, clinical, and immunogenicity data demonstrated biosimilarity with the reference product, Avastin.
The EC approval of Equidacent applies to 27 European Union (EU) member states, the United Kingdom (UK) and the European Economic Area (EEA) member states of Norway, Iceland, and Liechtenstein.
Equidacent is indicated for the following indications:
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
persistent, recurrent, or metastatic carcinoma of the cervix
Fujifilm Kyowa Kirin Biologics President and CEO Atsushi Matsumoto, Ph.D. commented, "We are proud that Centus received the approval of Equidacent from the European Commission. This demonstrates that Fujifilm Kyowa Kirin Biologics successfully utilized its deep scientific expertise needed to develop biosimilars in collaboration with AstraZeneca."
Centus was established in 2015 as a joint venture between Fujifilm Kyowa Kirin Biologics and AstraZeneca. Fujifilm Kyowa Kirin Biologics has granted an exclusive license to Centus for the development, manufacture, and commercialization of Equidacent on a worldwide basis. Centus has been proceeding with clinical development of Equidacent.
Data submitted to obtain the marketing authorization for Equidacent included similarity assessment in analytical testing, preclinical and clinical studies that demonstrated biosimilarity to the bevacizumab reference product, Avastin. The phase 3 clinical study, AVANA, conducted by Centus, demonstrated no clinically meaningful differences in terms of safety, efficacy, and immunogenicity compared with the reference product, Avastin, in non-small cell lung cancer patients. About Bevacizumab Bevacizumab is a recombinant humanized monoclonal antibody that blocks angiogenesis by inhibiting vascular endothelial growth factor A (VEGF-A). It reduces growth and metastasis of several solid tumors.