Pfizer-developed biosimilar medicine IXIFI™
(infliximab-qbtx) receives FDA approval for all eligible indications
NEW YORK--(BUSINESS WIRE)--
Pfizer Inc. (NYSE:PFE) announced today that the United States (U.S.)
Food and Drug Administration (FDA) has approved IXIFI™ (PF-06438179,
infliximab-qbtx), a chimeric human-murine monoclonal antibody (mAb)
against tumor necrosis factor, as a biosimilar to Remicade®
(infliximab)* for all eligible indications of the reference
product.1
The FDA has approved IXIFI as a treatment for patients with rheumatoid
arthritis, Crohn's disease, pediatric Crohn’s disease, ulcerative
colitis, ankylosing spondylitis, psoriatic arthritis, and plaque
psoriasis.1
FDA approval follows the acceptance of the IXIFI Biologics License
Application in April 2017 and is based on the totality of evidence
demonstrating a high degree of similarity to the reference product,
including the REFLECTIONS B537-02 study in patients with moderate to
severe active RA.2 The Phase 3, multi-national, randomized,
double blind, two-arm, parallel group study evaluated the safety,
efficacy, and immunogenicity of IXIFI versus Remicade administered
intravenously in combination with methotrexate to treat patients with
moderate to severely active RA who have had an inadequate response to
methotrexate therapy.2 The study met its primary endpoint of
ACR20 response (≥20% improvement by American College of Rheumatology
criteria) at Week 14, and was supported by data at week 30.3
Pfizer has a portfolio of three marketed biosimilar medicines outside
the U.S. including INFLECTRA® (infliximab), Retacrit (epoetin
zeta), and Nivestim (filgrastim); and a biosimilars pipeline consisting
of 13 distinct biosimilar molecules in various stages of development. As
part of its global biosimilars strategy, Pfizer supplies Celltrion’s
INFLECTRA® (infliximab-dyyb) in the U.S. and certain other
markets across the globe.
About IXIFI™
IXIFI™ (infliximab-qbtx) is a chimeric human-murine mAb against tumor
necrosis factor, approved as a biosimilar for all eligible indications
of the reference product.1
IXIFI has been approved in the U.S. for rheumatoid arthritis, Crohn's
disease, pediatric Crohn’s disease, ulcerative colitis, ankylosing
spondylitis, psoriatic arthritis, and plaque psoriasis.1
In February 2016, Sandoz acquired the rights from Pfizer for the
development, commercialization and manufacture of PF-06438179 in the 28
EU member states, as well as three of the four member states of the
European Free Trade Association (EFTA) (Iceland, Liechtenstein and
Norway) that form the European Economic Area (EEA). Under the terms of
the divestment, Pfizer retains commercialization and manufacturing
rights to PF-06438179 in countries outside the EEA.4
Please see full Prescribing
Information for IXIFI (infliximab- qbtx).
About Pfizer: 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
December 13, 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 IXIFI
(PF-06438179, infliximab-qbtx), 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
possibility of unfavorable new clinical data and additional analyses of
existing clinical data; whether and when any applications for IXIFI may
be filed with regulatory authorities in any other jurisdictions; whether
and when regulatory authorities in any such other jurisdictions (outside
the U.S.) may approve any such applications, 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; 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, 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.
*Remicade® is a U.S. registered trademark of Janssen Biotech,
Inc.
References
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1 IXIFI (infliximab-qbtx) Prescribing Information. New York.
NY: Pfizer Inc: 2017. Available at: https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/761072s000lbl.pdf.
Accessed December 2017.
2 Pfizer. Pfizer Announces
Positive Top-Line Results From Reflections B537-02 Study For PF-06438179
(Infliximab-Pfizer) A Potential Biosimilar To REMICADE® (Infliximab).
September 2016. Available at: http://www.pfizer.com/news/press-release/press-release-detail/pfizer_announces_positive_top_line_results_from_reflections_b537_02_study_for_pf_06438179_infliximab_pfizer_a_potential_biosimilar_to_REMICADE_infliximab.
Accessed December 2017.
3 Cohen SB, Alten R, Kameda H,
Rehman MI, Schumacher K, Schmitt S, Hua SY, Sewell KL. A Randomized,
Double-Blind Study Comparing PF-06438179/GP1111, a Potential Infliximab
Biosimilar, and Infliximab, Both in Combination with MTX, As Treatment
for Patients with Moderate to Severe Active RA Who Have Had an
Inadequate Response to MTX Therapy [abstract]. Arthritis Rheumatol.
2017; 69 (suppl 10). Available at: http://acrabstracts.org/abstract/a-randomized-double-blind-study-comparing-pf-06438179gp1111-a-potential-infliximab-biosimilar-and-infliximab-both-in-combination-with-mtx-as-treatment-for-patients-with-moderate-to-severe-active/.
Accessed December 2017.
4 Novartis. Sandoz strengthens
its biosimilars portfolio with acquisition of Pfizer's biosimilar
infliximab in EEA. Available at: https://www.novartis.com/news/media-releases/sandoz-strengthens-its-biosimilars-portfolio-acquisition-pfizers-biosimilar.
Accessed December 2017.
View source version on businesswire.com: http://www.businesswire.com/news/home/20171213006212/en/
Source: Pfizer Inc.