Centus Biotherapeutics, received European marketing authorization for Equidacent™, a biosimilar to bevacizumab (Avastin) for the treatment of several forms of cancer, including metastatic carcinoma of colon or rectum, unresectable advanced, metastatic, or recurrent non-small cell lung cancer (NSCLC), metastatic breast cancer, advanced and/or metastatic renal cancer, epithelial ovarian, fallopian tube, or primary peritoneal cancer and persistent, recurrent or metastatic cervical cancer. This approval makes it the fourth biosimilar in the EU market.
The approval is based on the results of pivotal phase 3 AVANA trial – conducted across multiple international locations with 731 patients with NSCLC, which demonstrated no clinically significant differences in terms of safety, efficacy and immunogenicity compared to the reference product Avastin.
Centus was established as a joint venture between AstraZeneca and Fujifilm Kyowa Kirin Biologics in 2015 to develop and advance biosimilar candidates. Fujifilm licensed exclusive worldwide rights for the development, manufacturing and commercialization of Equidacent™ to Centus.
The past few months have witnessed heightened deal making activity and regulatory approvals in the arena of oncology biosimilars. Also notable is the increasing participation of companies from emerging market companies, such as Henlius’ foray into the EU market, and the recent momentum in Bevacizumab with Samsung Biologics Aybintio and the partnership between Bei-Gene and Biothera. Oncology presents a huge market potential and even with multiple biosimilar candidates available, there exists a huge unmet need in various forms of cancer. We anticipate continued momentum in the space with more companies vying for a market share in both regulated and RoW markets, which currently have a large untapped market available.