European Commission approves Pfizer-beva monobiosimilar ZIRABEV ™ for treatment of multiple cancers
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Last Update: 2020-06-10
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Source: Internet
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Author: User
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recently, Pfizerannounced(http:// that the European Commission (EC) has approved the use of beva monobiothirepharmaceutical(http://ZIRABAEV ™ for the treatment of a variety of cancers, such as colon or rectal metastatic cancer, metastatic breast cancer, unretic advanced metastatic or recurrent non-small cell lung cancer (NSCLC), advanced and/or metastatic nephroblast stoic cancerabout ZIRABEV
ZIRABEV is a biosimilar of Roche's gene Tektronix heavydrug(http://Avastin (Avastin, generic name: bevacizumab, bevamono) ( mAb) working by specifically identifying and binding the endothelial growth factor (VEGF) protein to inhibit the formation of new blood cells (vascular) formationZIRABEV, PFIZER'S FIFTH BIOsimilar approved for use in Europe, has a strong portfolio of potential biosimilar candidates for late-stage development
product s
.http://The EC approval is based on a comprehensive data submission, demonstrating the biological similarity between ZIRABEV and the original drugThis includes the REFLECTIONS B739-03 Phase III Clinical Comparison Study, which showed clinical equivalence, and found no clinically significant difference between ZIRABEV and the original research product in the treatment of patients with late-stage non-scale NSCLCthe study was part of the overall REFLECTIONS Clinical Trial (http:// program, involving about 400 subjects the approval follows the positive recommendation of the European for Medicines (http:// Committee (CMPH) in December 2018, ZIRABEV has also received regulatory approval from the U.S Food and Drug Administration (
FDA (http://
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