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On June 28, Pfizer announced that the U.S. Food and Drug Administration (FDA) had approved the listing of its biosimilar drug ZIRABEV ™ (bevacizumab-bvzr). ZIRABEV is a biosimilar to bevele monotoma, which has been approved for treatment of five types of cancer: metastatic colorectal cancer; non-removable local late, recurrent or metastatic non-scaly non-small cell lung cancer (NSCLC); recurrent glioblastoma; metastatic renal cell cancer (RCC) and persistent, recurrent or metastatic cervical cancer.
Pfizer's official website screenshot
this FDA approval is based on a review of the biosimilarity of ZIRABEV and Bevalazumab. The data showed the clinical equivalence and non-difference of ZIRABEV.
"ZIRABEV is a useful complement to its approved indications treatment program, providing doctors with drugs that have similar safety and efficacy to reference products," said Dr. Niels Reinmuth of the Chest Oncology Department at asklepios Lung Clinic in Munich, Germany.
ALSO approved by the European Union in February 2019 for the treatment of metastatic colorectal cancer, metastatic breast cancer, non-removable late, metastatic or recurrent non-scaly non-small cell lung cancer (NSCLC), advanced and/or metastatic renal transparent cell cancer (RCC), and persistent, recurrent or metastatic cervical cancer."Biosimilars like ZIRABEV can help patients gain access to influential treatments that address the diverse needs of cancer patients," said Andy Schmeltz, global president of oncology at
Pfizer. "
.