Posted by Michael Wonder on 01 Oct 2020
Centus Biotherapeutics receives European marketing authorisation for Equidacent, biosimilar Avastin
29 September 2020 - Centus Biotherapeutics, a joint venture between Fujifilm Kyowa Kirin Biologics and AstraZeneca, today announced that the European Commission has granted the marketing authorization for Equidacent (Product Code: FKB238), the company’s biosimilar to Avastin (bevacizumab).
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 member states, the United Kingdom and the European Economic Area member states of Norway, Iceland, and Liechtenstein.
