THOUSAND OAKS, Calif.,
Jan. 25, 2016 /PRNewswire/
-- Amgen (NASDAQ:AMGN) today announced that the U.S. Food and
Drug Administration (FDA) has accepted for review Amgen's Biologics
License Application (BLA) for ABP 501, a biosimilar candidate to
Humira® (adalimumab).
"If approved, we believe ABP 501 could serve as an important
additional approved therapeutic option for patients with chronic
inflammatory conditions," said Sean E.
Harper, M.D., executive vice president of Research and
Development at Amgen. "We look forward to potentially expanding our
robust portfolio of approved products, and further demonstrating
our continued commitment to delivering high-quality medicines to
patients worldwide."
The BLA, submitted on Nov. 25,
2015, is based on analytical, clinical and pharmacokinetic
data. Phase 3 comparative efficacy and safety studies were
conducted in both moderate-to-severe plaque psoriasis and
moderate-to-severe rheumatoid arthritis. The Phase 3 studies met
their primary endpoints showing clinical equivalence to adalimumab.
Safety and immunogenicity of ABP 501 were also comparable to
adalimumab. Data to support the transition of adalimumab patients
to ABP 501 are included in the submission.
The FDA has set a Biosimilar User Fee Act (BsUFA) target action
date of Sept. 25, 2016, for ABP
501.
About ABP 501
ABP 501 is a biosimilar candidate to adalimumab, an anti-TNF-α
monoclonal antibody, which is approved in many regions for the
treatment of several inflammatory diseases. The active ingredient
of ABP 501 is an anti-TNF-α monoclonal antibody that has the same
amino acid sequence as adalimumab. ABP 501 has the same
pharmaceutical dosage form and strength as adalimumab (U.S.) and
adalimumab (EU).
About Amgen Biosimilars
Amgen Biosimilars is committed to building upon Amgen's
experience in the development and manufacturing of innovative human
therapeutics to expand Amgen's reach to patients with serious
illnesses. Biosimilars offer the potential to increase patient
access to vital medicines, and Amgen is well positioned to leverage
its 35 years of experience in biotechnology to create high-quality
biosimilars and reliably supply them to patients worldwide.
For more information, visit www.amgenbiosimilars.com and follow
us on www.twitter.com/amgenbiosim.
About Amgen
Amgen is committed to unlocking the potential of biology for
patients suffering from serious illnesses by discovering,
developing, manufacturing and delivering innovative human
therapeutics. This approach begins by using tools like advanced
human genetics to unravel the complexities of disease and
understand the fundamentals of human biology.
Amgen focuses on areas of high unmet medical need and leverages
its biologics manufacturing expertise to strive for solutions that
improve health outcomes and dramatically improve people's lives. A
biotechnology pioneer since 1980, Amgen has grown to be one of the
world's leading independent biotechnology companies, has reached
millions of patients around the world and is developing a pipeline
of medicines with breakaway potential.
For more information, visit www.amgen.com and follow us on
www.twitter.com/amgen.
Forward-Looking Statements
This news release contains forward-looking statements that are
based on management's current expectations and beliefs and are
subject to a number of risks, uncertainties and assumptions that
could cause actual results to differ materially from those
described. All statements, other than statements of historical
fact, are statements that could be deemed forward-looking
statements, including estimates of revenues, operating margins,
capital expenditures, cash, other financial metrics, expected
legal, arbitration, political, regulatory or clinical results or
practices, customer and prescriber patterns or practices,
reimbursement activities and outcomes and other such estimates and
results. Forward-looking statements involve significant risks and
uncertainties, including those discussed below and more fully
described in the Securities and Exchange Commission (SEC) reports
filed by Amgen, including Amgen's most recent annual report on Form
10-K and any subsequent periodic reports on Form 10-Q and Form 8-K.
Please refer to Amgen's most recent Forms 10-K, 10-Q and 8-K for
additional information on the uncertainties and risk factors
related to our business. Unless otherwise noted, Amgen is providing
this information as of Jan. 25, 2016
and expressly disclaims any duty to update information contained in
this news release.
No forward-looking statement can be guaranteed and actual
results may differ materially from those we project. Discovery or
identification of new product candidates or development of new
indications for existing products cannot be guaranteed and movement
from concept to product is uncertain; consequently, there can be no
guarantee that any particular product candidate or development of a
new indication for an existing product will be successful and
become a commercial product. Further, preclinical results do not
guarantee safe and effective performance of product candidates in
humans. The complexity of the human body cannot be perfectly, or
sometimes, even adequately modeled by computer or cell culture
systems or animal models. The length of time that it takes for us
to complete clinical trials and obtain regulatory approval for
product marketing has in the past varied and we expect similar
variability in the future. We develop product candidates internally
and through licensing collaborations, partnerships and joint
ventures. Product candidates that are derived from relationships
may be subject to disputes between the parties or may prove to be
not as effective or as safe as we may have believed at the time of
entering into such relationship. Also, we or others could identify
safety, side effects or manufacturing problems with our products
after they are on the market. Our business may be impacted by
government investigations, litigation and products liability
claims. If we fail to meet the compliance obligations in the
corporate integrity agreement between us and the U.S. government,
we could become subject to significant sanctions. We depend on
third parties for a significant portion of our manufacturing
capacity for the supply of certain of our current and future
products and limits on supply may constrain sales of certain of our
current products and product candidate development.
In addition, sales of our products are affected by the
reimbursement policies imposed by third-party payors, including
governments, private insurance plans and managed care providers and
may be affected by regulatory, clinical and guideline developments
and domestic and international trends toward managed care and
healthcare cost containment as well as U.S. legislation affecting
pharmaceutical pricing and reimbursement. Government and others'
regulations and reimbursement policies may affect the development,
usage and pricing of our products. In addition, we compete with
other companies with respect to some of our marketed products as
well as for the discovery and development of new products. We
believe that some of our newer products, product candidates or new
indications for existing products, may face competition when and as
they are approved and marketed. Our products may compete against
products that have lower prices, established reimbursement,
superior performance, are easier to administer, or that are
otherwise competitive with our products. In addition, while we
routinely obtain patents for our products and technology, the
protection offered by our patents and patent applications may be
challenged, invalidated or circumvented by our competitors and
there can be no guarantee of our ability to obtain or maintain
patent protection for our products or product candidates. We cannot
guarantee that we will be able to produce commercially successful
products or maintain the commercial success of our existing
products. Our stock price may be affected by actual or perceived
market opportunity, competitive position, and success or failure of
our products or product candidates. Further, the discovery of
significant problems with a product similar to one of our products
that implicate an entire class of products could have a material
adverse effect on sales of the affected products and on our
business and results of operations. Our efforts to integrate the
operations of companies we have acquired may not be successful. We
may experience difficulties, delays or unexpected costs and not
achieve anticipated benefits and savings from our ongoing
restructuring plan. Our business performance could affect or limit
the ability of our Board of Directors to declare a dividend or
their ability to pay a dividend or repurchase our common stock.
The scientific information discussed in this news release
related to our product candidates is preliminary and investigative.
Such product candidates are not approved by the U.S. Food and
Drug Administration (FDA) or the European Medicines Agency
(EMA), and no conclusions can or should be drawn regarding the
safety or effectiveness of the product candidates.
CONTACT:
Amgen, Thousand Oaks
Kristen Davis, 805-447-3008
(media)
Kristen Neese, 805-313-8267
(media)
Arvind Sood, 805-447-1060
(investors)
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SOURCE Amgen