NEW YORK--(BUSINESS WIRE)--
Pfizer Inc. (NYSE:PFE) today announced the United States (U.S.) Food and
Drug Administration (FDA) Oncologic Drugs Advisory Committee (ODAC)
recommended approval of the Company’s proposed epoetin alfa biosimilar
across all indications. This marks the first time a biosimilar
erythropoiesis-stimulating agent (ESA) has been recommended for approval
by a U.S. FDA Advisory Committee.
The Committee’s favorable recommendation was based on its review of the
totality of evidence, including demonstration of comparable efficacy and
safety of biosimilar epoetin alfa to its reference product, Epogen®
and Procrit® (epoetin alfa).[1]
The company is seeking FDA approval of the following indications:
-
Treatment of anemia due to:
-
Chronic Kidney Disease (CKD) in patients on dialysis and not on
dialysis.
-
Zidovudine in HIV-infected patients.
-
The effects of concomitant myelosuppressive chemotherapy, and upon
initiation, there is a minimum of two additional months of planned
chemotherapy.
-
Reduction of allogeneic red blood cell (RBC) transfusions in patients
undergoing elective, noncardiac, nonvascular surgery.
“The Committee’s recommendation reinforces the potential value of
biosimilars in expanding access to additional high-quality treatment
options for the patients in the U.S. who need them,” said Diem Nguyen,
Global President, Americas, Pfizer Essential Health. “Following the
approval and launch of INFLECTRA® (infliximab-dyyb) in 2016,
this positive recommendation – a first for a proposed ESA biosimilar –
marks an important milestone for Pfizer’s U.S. biosimilars portfolio.”
The FDA will take the Committee’s recommendation into consideration
before taking action on the Biologics License Application (BLA) for the
proposed epoetin alfa biosimilar across all indications.
Pfizer has entered into an agreement with Vifor Pharma Inc. for the
commercialization of its proposed epoetin alfa biosimilar in certain
channels.
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,
LinkedIn,
YouTube
and like us on Facebook at Facebook.com/Pfizer.
DISCLOSURE NOTICE: The information contained in this release is as of
May 25, 2017. 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 epoetin alfa 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; whether and when any
applications for biosimilar epoetin alfa or any other biosimilars in
development may be filed with regulatory authorities in any
jurisdictions; whether and when regulatory authorities in any such
jurisdictions may approve any such applications for biosimilar epoetin
alfa or any other biosimilars in development, 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; intellectual property and/or litigation implications;
decisions by regulatory authorities regarding labeling and other matters
that could affect the availability or commercial potential of biosimilar
epoetin alfa or any other biosimilars in development; 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, 2016 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.
______________________
[1] Epogen® is a registered U.S. trademark of
Amgen Inc.; Procrit® is a registered U.S. trademark of
Johnson & Johnson
View source version on businesswire.com: http://www.businesswire.com/news/home/20170525005848/en/
Source: Pfizer Inc.