Pfizer announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion and recommended marketing authorization for Zirabev (bevacizumab), a potential biosimilar to Avastin (bevacizumab).
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.
Pfizer biosimilars development vice president Joe McClellan said: “If approved, ZIRABEV has the potential to expand access to this life-changing biologic cancer therapy for appropriate patients and healthcare professionals across Europe.
“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.
As part of the overall REFLECTIONS clinical trial program, ZIRABEV has been studied in approximately 400 subjects.
ZIRABEV is Pfizer’s second therapeutic oncology biosimilar to receive a positive CHMP opinion from the EMA in 2018.
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.
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.
Source: Company Press Release