Pfizer receives positive CHMP opinion for oncology biosimilar, ZIRABEV™ (bevacizumab)

PfizerPfizer 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)

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.

Most Popular Now

Bayer, Brigham and Women’s Hospital, and Massachus…

Bayer and Partners HealthCare's founding members Brigham and Women's Hospital (BWH) and Massachusetts General Hospital (MGH) today announced the launch of a joint lab to ...

AstraZeneca divests rights for Losec to Cheplaphar…

AstraZeneca has agreed to sell the global commercial rights, excluding China, Japan, the US and Mexico, for Losec (omeprazole) and associated brands to Cheplapharm Arznei...

Cause of antibiotic resistance identified

Scientists have confirmed for the first time that bacteria can change form to avoid being detected by antibiotics in the human body. Studying samples from elderly patient...

Amgen announces positive results from two Phase 3 …

Amgen (NASDAQ:AMGN) today announced that the results of a prespecified interim analysis of an open-label, randomized, controlled global multicenter Phase 3 trial (2012021...

Brilinta monotherapy in high-bleeding risk patient…

New data from TWILIGHT, a Phase IV independent trial (funded by AstraZeneca), showed that in patients at high-bleeding risk who underwent PCI and completed 3 months of du...

Novartis and Microsoft announce collaboration to t…

Novartis announced an important step in reimagining medicine by founding the Novartis AI innovation lab and by selecting Microsoft as its strategic AI and data-science pa...

Ian Read to retire as Executive Chairman of Pfizer…

Following its regularly scheduled meeting, the Board of Directors of Pfizer Inc. (NYSE:PFE) today announced that Executive Chairman of the Board Ian C. Read has chosen to...

Discovery of new source of cancer antigens may exp…

For more than a decade, scientist Stephen Albert Johnston and his team at Arizona State University's Biodesign Institute have pooled their energies into an often scoffed-...

Chinese activists protest the use of traditional t…

In the West, the number of people challenging scientific authority has been growing in past decades. This has, among other things, led to a decline in the support for mas...

Cheaper drug just as effective protecting heart in…

A new clinical trial conducted at The Ohio State University Wexner Medical Center found a cost-effective generic medication works just as well as a more expensive drug in...

Bayer inks deals with eleven startups under G4A Di…

Bayer announced today that the company has signed collaboration agreements with eleven digital health startups. As part of the program, Bayer will support these startup c...

Akcea and Pfizer Inc. announce licensing agreement…

Akcea Therapeutics, Inc. (NASDAQ: AKCA), a majority-owned affiliate of Ionis Pharmaceuticals, Inc. (NASDAQ: IONS) and Pfizer Inc. (NYSE:PFE), today announced that the com...