ZIRABEV™ (bevacizumab), a potential biosimilar
to Avastin®* (bevacizumab), is Pfizer’s second therapeutic oncology
biosimilar to receive a positive CHMP opinion in Europe in 2018
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
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
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DISCLOSURE NOTICE: The information contained in this release is
as of December 14, 2018. Pfizer assumes no obligation to update
forward-looking statements contained in this release as the result
of new information or future events or developments.
This release contains forward-looking information about ZIRABEV,
Pfizer’s potential bevacizumab biosimilar, and Pfizer’s biosimilars
portfolio, including their potential benefits, that involve
substantial risks and uncertainties that could cause actual results
to differ materially from those expressed or implied by such
statements. Risks and uncertainties include, among other things,
the uncertainties inherent in research and development, including
the ability to meet anticipated clinical trial commencement and
completion dates and regulatory submission dates, as well as the
possibility of unfavorable clinical trial results, including
unfavorable new clinical data and additional analyses of existing
clinical data; the risk that clinical trial data are subject to
differing interpretations, and, even when we view data as
sufficient to support the safety and/or effectiveness of a product
candidate, regulatory authorities may not share our views and may
require additional data or may deny approval altogether; whether
regulatory authorities will be satisfied with the design of and
results from our clinical studies; whether and when applications
for ZIRABEV or any other potential biosimilars may be filed in any
other jurisdictions; whether and when the European Commission may
approve the pending application for ZIRABEV in the EU and whether
and when any such other applications for ZIRABEV or other potential
biosimilars that may be pending or filed may be approved by
regulatory authorities, which will depend on the assessment by such
regulatory authorities of the benefit-risk profile suggested by the
totality of the efficacy and safety information submitted and, if
approved, whether ZIRABEV or such other potential biosimilars will
be commercially successful; intellectual property and/or litigation
implications; decisions by regulatory authorities regarding
labeling and other matters that could affect the availability or
commercial potential of ZIRABEV or other potential biosimilars; and
competitive developments.
A further description of risks and uncertainties can be found in
Pfizer’s Annual Report on Form 10-K for the fiscal year ended
December 31, 2017 and in its subsequent reports on Form 10-Q,
including in the sections thereof captioned “Risk Factors” and
“Forward-Looking Information and Factors That May Affect Future
Results”, as well as in its subsequent reports on Form 8-K, all of
which are filed with the U.S. Securities and Exchange Commission
and available at www.sec.gov and www.pfizer.com.
________________________________
* 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.
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version on businesswire.com: https://www.businesswire.com/news/home/20181214005297/en/
Media Contact:Thomas Biegi+1(212) 733
2204Thomas.Biegi@pfizer.com
Dervila Keane+353 14676631Dervila.M.Keane@pfizer.com
Investor Contact:Ryan Crowe+1 (212) 733
8160Ryan.Crowe@pfizer.com
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