Centus’ Equidacent became Europe’s fourth bevacizumab biosimilar to receive marketing authorization.
Centus Biotherapeutics said that it has received marketing authorization for its bevacizumab biosimilar (Equidacent) from the European Commission (EC) for the treatment of several types of cancer.
The biosimilar references Genetech’s Avastin and is the fourth bevacizumab biosimilar to receive EC approval, following Amgen’s Mvasi in January 2018, Pfizer’s Zirabev in February 2019, and Samsung Bioepis’ Aybintio in August 2020.
The approval follows the Committee for Medicinal Products for Human Use’s positive opinion for the product in July 2020.
Equidacent received indications for the treatment of metastatic carcinoma of the colon or rectum; metastatic breast cancer; unresectable advanced, metastatic, or recurrent non-small cell lung cancer (NSCLC); advanced and/or metastatic renal cell cancer; epithelial ovarian, fallopian tube, or primary peritoneal cancer; and persistent, recurrent, or metastatic carcinoma of the cervix.
Data submitted to obtain marketing authorization included results from the phase 3 AVAVA trial, which demonstrated no clinically meaningful differenced in terms of safety, efficacy, and immunogenicity between Equidacent and Avastin in patients with NSCLC.
Another ongoing phase 3 trial to compare the safety and efficacy of the biosimilar and reference product in combination with paclitaxel and carboplatin in patients with NSCLC, is expected to be completed by February 2022.
The EC’s approval allows Equidacent to be marketing in the 27 European Union member states, the United Kingdom, and the European Economic Area states including Norway, Iceland, and Liechtenstein.
In 2015, Centus was established as a joint venture between Fujifilm Kyowa Kirin Biologics and AstraZeneca. Centus was granted an exclusive license by Fujifilm Kyowa Kirin Biologics for the development, manufacture, and commercialization of Equidacent that applies globally.
In July 2020, the FDA approved Fujifilm Kyowa Kirin Biologics’ adalimumab biosimilar (Hulio), although it will not be brought to market in the United States until 2023. Hulio launched in Europe in 2018.