Pfizer Provides Update on Proposed Trastuzumab Biosimilar
April 23 2018 - 7:45AM
Business Wire
Pfizer Inc. (NYSE:PFE) today announced that it received a
Complete Response Letter (CRL) from the United States Food and Drug
Administration (FDA) in response to the Biologics License
Application for the company’s proposed trastuzumab biosimilar. In
the CRL, the FDA highlighted the need for additional technical
information. The additional requested information does not relate
to safety or clinical data submitted in the application. Pfizer is
working closely with the FDA to address the contents of the letter
and remains committed to bringing this important medicine to
patients in the U.S.
Pfizer believes that biosimilars are critically important to the
future of cancer care, with the potential to increase patient
access to life-changing therapies that will help address the
evolving needs of healthcare systems, patients, physicians and
payers.
Pfizer Inc.: 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 April 23, 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 Pfizer’s
proposed trastuzumab biosimilar, including its potential benefits,
that involves 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 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; uncertainties regarding the company’s ability to
address the comments in the complete response letter to the
satisfaction of the FDA; whether and when any applications for
Pfizer’s proposed trastuzumab biosimilar may be filed with
regulatory authorities in any other jurisdictions; whether and when
the FDA may approve the biologics license application for Pfizer’s
proposed trastuzumab biosimilar and whether and when regulatory
authorities in any other jurisdictions may approve any such other
applications that are pending or that may be filed for Pfizer’s
proposed trastuzumab biosimilar, 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 Pfizer’s proposed
trastuzumab biosimilar 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 Pfizer’s
proposed trastuzumab biosimilar ; 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, 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 10-Q and 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.
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version on businesswire.com: https://www.businesswire.com/news/home/20180423005423/en/
Pfizer Inc.Media:Thomas Biegi, +1
212-733-2204Thomas.Biegi@pfizer.comorInvestor:Ryan Crowe, +1
212-733-8160Ryan.Crowe@pfizer.com
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