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
NEW YORK--(BUSINESS WIRE)--
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 all who rely on us. We routinely post information that
may be important to investors on our website at www.pfizer.com.
In addition, to learn more, please visit us on www.pfizer.com and
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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
itssubsequent 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.
View source version on businesswire.com:
https://www.businesswire.com/news/home/20181214005297/en/
Media Contact:
Thomas Biegi
+1(212) 733 2204
Thomas.Biegi@pfizer.com
Dervila Keane
+353 14676631
Dervila.M.Keane@pfizer.com
Investor Contact:
Ryan Crowe
+1 (212) 733 8160
Ryan.Crowe@pfizer.com
Source: Pfizer Inc.