FDA OKs Pfizer's Biosimilar to Bevacizumab
Pfizerâ€™s bevacizumab-bvzr (Zirabev) demonstrated clinical equivalence and no clinically meaningful differences compared with the reference product.
Officials with the FDA have approved bevacizumab-bvzr (Zirabev, Pfizer), a biosimilar to bevacizumab (Avastin), for the treatment of 5 types of cancer, according to a press release.
Bevacizumab-bvzr is indicated for the treatment of 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.
A monoclonal antibody biosimilar, bevacizumab-bvzr works by inhibiting the formation of new blood cells by specifically recognizing and binding to vascular endothelial growth factor protein.
The approval was based on a review of a comprehensive data package which demonstrated the biosimilarity of bevacizumab-bvzr to the reference product. In particular, the REFLECTIONS B7391003 clinical comparative study showed clinical equivalence and no clinically meaningful differences between the biosimilar and the reference product in patients with advanced non-squamous NSCLC. The study enrolled 719 patients and demonstrated equivalence in the primary end point of objective response rate of the biosimilar versus the reference when taken in combination with carboplatin/paclitaxel for first-line treatment of NSCLC.
“Zirabev represents a welcome addition to the treatment armamentarium in its approved indications, potentially providing physicians with a medicine that has a similar safety profile and efficacy as the reference product,” lead study author Niels Reinmuth, department of thoracic oncology, Asklepios Lung Clinic, said in a statement. “The FDA’s approval of Zirabev may provide an important new option for the treatment of multiple forms of cancer.”
Pfizer’s bevacizumab biosimilar is also approved in the European Union for metastatic carcinoma of the colon or rectum, metastatic breast cancer, NSCLC, advanced and/or metastatic RCC, and persistent, recurrent or metastatic carcinoma of the cervix.
“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,” Andy Shmeltz, global president of Pfizer Oncology, said in a statement. “We are proud to add Zirabev to our growing oncology portfolio for US patients living with a wide variety of tumor types.”
Pfizer receives US FDA approval for its oncology biosimilar, Zirabev (bevacizumab-bvzr) [news release]. Pfizer. https://www.pfizer.com/news/press-release/press-release-detail/pfizer_receives_u_s_fda_approval_for_its_oncology_biosimilar_zirabev_bevacizumab_bvzr