"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)
Working together for a healthier world®At Pfizer, we apply science and our global resources to bring therapies to people that extend and significantly improve their lives. We strive to set the standard for quality, safety and value in the discovery, development and manufacture of health care products. Our global portfolio includes medicines and vaccines, as well as, many of the world's best-known consumer health care products. Every day, Pfizer colleagues work across developed and emerging markets to advance wellness, prevention, treatments and cures that challenge the most feared diseases of our time. Consistent with our responsibility as one of the world's premier innovative biopharmaceutical companies, we collaborate with health care providers, governments and local communities to support and expand access to reliable, affordable health care around the world. For more than 150 years, we have worked to make a difference for all who rely on us.
* Avastin® is a registered trademark of Genentech
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.