FDA Advisory Committee Recommends Approval of Pfizer’s Proposed Biosimilar to Epogen®/Procrit® Across All Indications
26 May 2017 - 3:16AM
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
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in the discovery, development and manufacture of health care
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well as many of the world's best-known consumer health care
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Consistent with our responsibility as one of the world's premier
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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 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
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version on businesswire.com: http://www.businesswire.com/news/home/20170525005848/en/
Pfizer Inc.Media:Rachel HooperM: +1
916-708-1868Rachel.Hooper@pfizer.comorInvestor:Ryan CroweO: +1
212-733-8160Ryan.Crowe@pfizer.com
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