NEW YORK--(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 follow us on Twitter at @Pfizer
and @Pfizer_News,
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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.
View source version on businesswire.com: https://www.businesswire.com/news/home/20180423005423/en/
Source: Pfizer Inc.