A joint venture between Fujifilm Kyowa Kirin Biologics and AstraZeneca has received a positive biosimilar opinion from the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP).
Centus Biotherapeutics has received a positive opinion from the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) for its bevacizumab biosimilar (Equidacent) for multiple forms of cancer.
The reference product is Genentech’s Avastin. Centus, which is a joint venture between Fujifilm Kyowa Kirin Biologics and AstraZeneca, seeks indications for 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.
The CHMP opinion comes after Centus submitted clinical trial data as part of the marketing authorization application for the biosimilar, which included a comparative analysis of Equidacent and the reference product.
“I am delighted that CHMP decided to recommend the approval of the proposed biosimilar bevacizumab. We will continue our efforts to bring high quality and affordable biosimilars to patients throughout European countries,” said Atsushi Matsumoto, PhD, president and CEO of Fudifilm Kyowa Kirin Biologics, in a statement.
Clinical Trials of Equidacent
Phase 3 trial (AVANA) results demonstrated no clinically meaningful differences in terms of safety, efficacy, and immunogenicity between Equidacent and the reference product in patients with NSCLC.
Currently, another phase 3 trial is ongoing to compare the safety and efficacy of the biosimilar and reference product in combination with paclitaxel and carboplatin in patients with NSCLC.
A decision from the European Commission on whether the product can be marketed is expected in September 2020. If the product is approved, Centus would have marketing authorization in 27 European Union member states, the United Kingdom, and the European Economic Area member states of Norway, Iceland, and Lichtenstein.
As a joint venture between Fujifilm Kyowa Kirin Biologics and AstraZeneca PLC, Centus has exclusive license for the development, manufacture, and commercialization of Equidacent.
Recently, the FDA approved Fujifilm Kyowa Kirin Biologics's Hulio adalimumab biosimilar, although it won't appear on the US market until 2023. Hulio launched in Europe in 2018.