Pfizer Commends The FDA Advisory Committee’s Vote To Approve Proposed Biosimilar Infliximab, The First Biosimilar Monoclona...
February 09 2016 - 6:57PM
Business Wire
Pfizer Inc. commends today’s recommendation by the United States
(U.S.) Food and Drug Administration’s (FDA) Arthritis Advisory
Committee to approve the investigational biosimilar infliximab
(CT-P13) across all eligible indications by a vote of 21 to three.
Celltrion's proposed biosimilar infliximab, to which Pfizer holds
exclusive U.S. commercialization rights, is the first biosimilar
monoclonal antibody (mAb) therapy to be reviewed by the FDA for
licensure in the U.S., and is only the second biosimilar to be
recommended for approval by a U.S. FDA Advisory Committee.
The FDA is considering the proposed biosimilar infliximab for
all indications of the reference product eligible for licensure,
including the treatment of rheumatoid arthritis, adult ulcerative
colitis, plaque psoriasis, psoriatic arthritis, ankylosing
spondylitis, and adult and pediatric Crohn’s disease.
“As a leading global biosimilars company and having seen
firsthand the impact of biosimilars in other countries during the
past eight years, we applaud the FDA Advisory Committee for
reaching this positive recommendation," said Sumant Ramachandra,
M.D., Ph.D., senior vice president, Research & Development,
Global Established Pharma, Pfizer Inc. “Biosimilars represent an
exciting opportunity to expand patient access to important
treatments, and we are proud to be at the forefront of helping
shape and prepare the U.S. market for these therapies.”
The Advisory Committee’s recommendation to approve the proposed
biosimilar infliximab for all eligible indications, based on
extrapolation of data, marks a critical next step in helping create
a sustainable market for biosimilars in the U.S. Pfizer recognizes
the importance of this milestone in more broadly advancing
opportunities to expand patient access to high-quality, lower-cost
alternative treatment options through biosimilars.
The FDA is not bound by the Advisory Committee’s recommendation,
but the Agency takes its advice into consideration when reviewing
the biologics license application (BLA) for medicinal products.
“We look forward to the FDA’s continued review and, while
awaiting its decision and certain other factors, we are moving
ahead with the preparation of our launch plans for 2016,” said
Jenny Alltoft, global biosimilars lead, Pfizer Inc. “Pfizer remains
committed to bringing these important medicines to patients in the
U.S. as quickly as possible.”
Hospira, now a Pfizer company, entered into a business
cooperation agreement with Celltrion in 2009 for several biosimilar
products, including a potential biosimilar to Remicade®
(infliximab).1 Pfizer has exclusive commercialization rights to the
proposed biosimilar infliximab in the U.S. and certain other
jurisdictions.
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 healthcare
products. Our global portfolio includes medicines and vaccines as
well as many of the world's best-known consumer healthcare
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, Pfizer has worked to make a difference for
all who rely on us. For more information, please visit us at
www.pfizer.com. In addition, to learn more, 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 February 9, 2016. 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 the
potential biosimilar infliximab, 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;
whether and when any applications for proposed biosimilar
infliximab or label updates for proposed biosimilar infliximab may
be filed with regulatory authorities in any other jurisdictions;
whether and when the FDA may approve the BLA for proposed
biosimilar infliximab and whether and when regulatory authorities
in other jurisdictions may approve any such other applications that
are pending or that may be filed for proposed biosimilar
infliximab, 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; relationship with the
application sponsor; decisions by regulatory authorities regarding
labeling and other matters that could affect the availability or
commercial potential of proposed biosimilar infliximab; 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, 2014, 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.
1 Remicade® is a registered U.S. trademark of Janssen Biotech,
Inc.
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version on businesswire.com: http://www.businesswire.com/news/home/20160209006878/en/
Pfizer Inc.Media: Neha Wadhwa, (212) 733-2835Investor: Charles
Triano, (212) 733-3901
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