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The committee has given a positive opinion on the biosimilar bevacizumab for several cancer indications.
Centus Biotherapeutics, a joint venture between AstraZeneca and Fujifilm Kyowa Kirin Biologics, has received a positive opinion from the European Medicines Agency's (EMA’s) Committee for Medicinal Products for Human Use (CHMP) for Equidacent, a biosimilar to Avastin (bevacizumab), Roche’s innovator biologic. Avastin is Roche’s top-selling drug, earning approximately CHF $7 billion (US$7.6 billion) in 2019 sales (1).
The positive opinion applies to the use of Equidacent for treating several cancers, including 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; and persistent, recurrent, or metastatic carcinoma of the cervix, Centus announced in a July 27, 2020 press release.
A decision on the marketing authorization application for the drug is expected to be delivered by the European Commission in September 2020. If approved, Equidacent will be authorized for use in the 27 European Union member countries, the United Kingdom, and the European Economic Area member states of Norway, Iceland, and Liechtenstein.
"We are very happy receiving a positive CHMP opinion toward approval of Equidacent, our bevacizumab biosimilar. We will continue with every effort to bring Equidacent to patients and healthcare professionals," said Hiroshi Ohashi from Fujifilm Kyowa Kirin Biologics, who serves as president and product development team at Centus, in the company press release.
"This represents a great collaborative effort between our shareholders to bring high quality and affordable medicines to our patients worldwide," added Kelvin Tsang from AstraZeneca, who serves as product development team co-lead at Centus, in the press release.
1. Roche, “Finance Report 2019,” roche.com/investors, March 2020.
Source: Centus Biotherapeutics