Centus bags approval for Avastin biosimilar in Europe

Centus Biotherapeutics, a joint venture between Fujifilm Kyowa Kirin Biologics and AstraZeneca (LSE: AZN), has announced that its biosimilar to Roche’s (ROG: SIX) Avastin (bevacizumab) has been approved by the European Commission (EC).

The authorization of the product, which has been branded as Equidacent, follows the adoption of a positive opinion by the European Medicines Agency’s 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 drug. This approval applies to 27 European Union (EU) member states, the UK and the European Economic Area (EEA) member states of Norway, Iceland, and Liechtenstein.

Equidacent has been approved for the treatment of the same types of cancer as Avastin, including metastatic carcinoma of the colon or rectum (mCRC), metastatic breast cancer (mBC), non-small cell lung cancer (NSCLC), advanced and/or metastatic renal cell cancer (mRCC), epithelial ovarian, fallopian tube and primary peritoneal cancer and cervical cancer.