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The company’s biosimiliar to Roche’s Avastin (bevacizumab) received a positive opinion for marketing authorization from the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP).
Pfizer announced on Dec. 14, 2018 that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion for recommending marketing authorization for Zirabev (bevacizumab), a potential biosimilar to Avastin (bevacizumab).
Zirabev is a monoclonal antibody for the treatment of 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; and persistent, recurrent, or metastatic carcinoma of the cervix.
Pfizer reports that the regulatory submission is supported with a comprehensive data package and evidence demonstrating biosimilarity to the originator product. Pfizer states that Zirabev is the second therapeutic oncology biosimilar to receive a positive CHMP opinion from EMA in 2018.