Pfizer Inc. (NYSE:PFE) today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion, recommending marketing authorization for ZIRABEV™ (bevacizumab), a potential biosimilar to Avastin (bevacizumab). (1) ZIRABEV is a monoclonal antibody for the treatment of metastatic carcinoma of the colon or rectum, metastatic breast cancer, unresectable advanced, metastatic or recurrent non-small cell lung cancer (NSCLC), advanced and/or metastatic renal cell cancer and persistent, recurrent or metastatic carcinoma of the cervix.(2)
"If approved, ZIRABEV has the potential to expand access to this life-changing biologic cancer therapy for appropriate patients and healthcare professionals across Europe," said Joe McClellan, Vice President, Biosimilars Development at Pfizer. "Today's positive CHMP opinion underscores Pfizer’s strong heritage in oncology and its ongoing commitment to bringing high-quality biosimilars to market, providing additional options for people living with certain cancers."
The regulatory submission is supported with a comprehensive data package and evidence demonstrating biosimilarity to the originator product. This includes results from the phase 3 REFLECTIONS B739-03 clinical comparative study, which demonstrated clinical equivalence and found no clinically meaningful differences between ZIRABEV and Avastin in patients with advanced non-squamous NSCLC.(3) As part of the overall REFLECTIONS clinical trial program, ZIRABEV has been studied in approximately 400 subjects.(3,4)
ZIRABEV is Pfizer's second therapeutic oncology biosimilar to receive a positive CHMP opinion from the EMA in 2018.(5) Pfizer has a robust portfolio of potential biosimilar candidates in mid to late stage development and we are confident about our ability to bring these important medicines to the patients who need them around the world.(6)
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1. European Commission Community Register. Zirabev Product Information. Available at: https://www.ema.europa.eu/documents/smop-initial/chmp-summary-positive-opinion-zirabev_en.pdf Accessed December 2018.
2. European Medicines Agency. Avastin. EPAR Summary of Product Characteristics. Available at https://www.ema.europa.eu/documents/overview/avastin-epar-summary-public_en.pdf. Accessed December 2018.
3. Socinski MA., Von Pawel J., Kasahara K., et al. A comparative clinical study of PF-06439535, a candidate bevacizumab biosimilar, and reference bevacizumab, in patients with advanced nonsquamous non-small cell lung cancer. Abstract 109. Presented at ASCO 2018.
4. Knight, B., Rassam, D., Liao, S. et al. A phase I pharmacokinetics study comparing PF-06439535 (a potential biosimilar) with bevacizumab in healthy male volunteers. Cancer Chemother Pharmacol (2016) 77: 839-846.
5. European Medicines Agency. Trazimera. EPAR Medicine Overview. Available at https://www.ema.europa.eu/documents/overview/trazimera-epar-medicine-overview_en.pdf. Accessed December 2018.
6. Pfizer Pipeline (as of October 30, 2018). Pfizer. Available at https://www.pfizer.com/sites/default/files/product-pipeline/Pipeline_Update_30OCT2018.pdf. Accessed December 2018.