Pfizer’s oncology biosimilar to Avastin has been approved in the US for treating five types of cancer.
Zirabev can now be used to treat metastatic colorectal cancer; unresectable, locally advanced, recurrent or metastatic non-squamous non-small cell lung cancer (NSCLC); recurrent glioblastoma; metastatic renal cell carcinoma (RCC); and persistent, recurrent or metastatic cervical cancer.
“Biosimilars like Zirabev can help increase access to impactful therapies, driving market competition that may ultimately lower costs and help address the diverse needs of patients living with cancer,” said Andy Schmeltz, Global President of Pfizer Oncology.
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.
Zirabev is Pfizer’s second oncology monoclonal antibody (mAb) biosimilar to be approved by the FDA, following the approval of Trazimera (trastuzumab-qyyp) in March 2019.
Zirabev was also approved for use in the EU 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.