The FDA approval was based on review of a comprehensive data package which demonstrated biosimilarity of Zirabev to the reference product.
This includes results from the REFLECTIONS B7391003 clinical comparative study, which showed clinical equivalence and found no clinically meaningful differences between Zirabev and the reference product in patients with advanced non-squamous NSCLC.
Biosimilars have been a significant catalyst for change for the healthcare industry over the last decade, with the potential to create a more sustainable healthcare system.
With more than 10 years of global in-market experience and six approved biosimilar products in the US, Pfizer is proud to be a leader and at the forefront of this vital healthcare segment.
Zirabev is Pfizer's second oncology monoclonal antibody biosimilar to be approved by the FDA, following the FDA approval of Trazimera (trastuzumab-qyyp) in March 2019.
Zirabev was also approved for use in the European Union in February 2019 for the treatment of metastatic carcinoma of the colon or rectum, metastatic breast cancer, unresectable advanced, metastatic or recurrent NSCLC, advanced and/or metastatic RCC and persistent, recurrent or metastatic carcinoma of the cervix.
Zirabev is a mAb biosimilar of the reference product, Avastin, which works by inhibiting the formation of new blood cells (angiogenesis) by specifically recognizing and binding to vascular endothelial growth factor protein.
As part of the REFLECTIONS clinical trial programme, Zirabev has been studied in nearly 400 patients to date.
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