Holzkirchen, January 16, 2018
- Sandoz, a Novartis division and the global leader in biosimilar
medicines, announced today that the US Food and Drug Administration
(FDA) has accepted its Biologics License Application (BLA),
submitted under the 351 (k) pathway, for proposed biosimilar
adalimumab to the reference medicine, Humira®*.
"When patients are dealing with a chronic disease,
it is imperative they have access to important medication that will
help best manage their health." said Mark Levick, Global Head of
Development, Biopharmaceuticals, Sandoz. "The FDA's acceptance of
the regulatory submission for our biosimilar adalimumab brings us
one step closer to offering a portfolio of options to the millions
of patients in the US who suffer from an inflammatory disease."
Adalimumab is indicated for the treatment of a
number of inflammatory diseases including rheumatoid arthritis,
plaque psoriasis, Crohn's disease and ulcerative colitis[1].
Rheumatoid arthritis alone affects approximately 1.5 million
Americans with 200,000 new cases diagnosed each year[5], [6]. Women
are disproportionately (3:1) affected by the disease[5].
The comprehensive data package submitted to the
FDA, which comprises analytical, preclinical and clinical data, is
expected to demonstrate that Sandoz proposed biosimilar adalimumab
matches the reference biologic in terms of safety, efficacy and
quality. Clinical studies submitted to the FDA include a
pharmacokinetic study in healthy volunteers and a Phase III
confirmatory safety and efficacy study in patients with moderate to
severe chronic plaque-type psoriasis (ADACCESS)[2]-[4].
Sandoz is committed to increasing patient access
to high-quality biosimilars. As the global leader in biosimilars,
Sandoz has five biosimilars marketed in various countries
worldwide, as well as a leading global pipeline. Sandoz is
well-positioned to continue leading the biosimilars industry based
on our experience and capabilities in development, manufacturing
and commercialization. As a division of Novartis, the first global
healthcare company to establish a leading position in both
innovative and off-patent medicines, we benefit strongly from this
unique blend of experience and expertise in many different market
environments.
Disclaimer
This press release contains forward-looking statements within the
meaning of the United States Private Securities Litigation Reform
Act of 1995. Forward-looking statements can generally be identified
by words such as "potential," "can," "will," "plan," "expect,"
"anticipate," "look forward," "believe," "committed,"
"investigational," "pipeline," "launch," or similar terms, or by
express or implied discussions regarding potential marketing
approvals, new indications or labeling for the investigational or
approved biosimilar products described in this press release, or
regarding potential future revenues from such products. You should
not place undue reliance on these statements. Such forward-looking
statements are based on our current beliefs and expectations
regarding future events, and are subject to significant known and
unknown risks and uncertainties. Should one or more of these risks
or uncertainties materialize, or should underlying assumptions
prove incorrect, actual results may vary materially from those set
forth in the forward-looking statements. There can be no guarantee
that the investigational or approved products described in this
press release will be submitted or approved for sale or for any
additional indications or labeling in any market, or at any
particular time. Neither can there be any guarantee that, if
approved, such biosimilar products will be approved for all
indications included in the reference product's label. Nor can
there be any guarantee that such products will be commercially
successful in the future. In particular, our expectations regarding
such products could be affected by, among other things, the
uncertainties inherent in research and development, including
clinical trial results and additional analysis of existing clinical
data; regulatory actions or delays or government regulation
generally; the particular prescribing preferences of physicians and
patients; competition in general, including potential approval of
additional biosimilar versions of such products; global trends
toward health care cost containment, including government, payor
and general public pricing and reimbursement pressures; litigation
outcomes, including intellectual property disputes or other legal
efforts to prevent or limit Sandoz from selling its products;
general economic and industry conditions, including the effects of
the persistently weak economic and financial environment in many
countries; safety, quality or manufacturing issues, and other risks
and factors referred to in Novartis AG's current Form 20-F on file
with the US Securities and Exchange Commission. Novartis is
providing the information in this press release as of this date and
does not undertake any obligation to update any forward-looking
statements contained in this press release as a result of new
information, future events or otherwise.
About
Sandoz
Sandoz is a global leader in generic pharmaceuticals and
biosimilars. As a division of the Novartis Group, our purpose is to
discover new ways to improve and extend people's lives. We
contribute to society's ability to support growing healthcare needs
by pioneering novel approaches to help people around the world
access high-quality medicine. Our portfolio of approximately 1000
molecules, covering all major therapeutic areas, accounted for 2016
sales of USD 10.1 billion. In 2016, our products reached well over
500 million patients and we aspire to reach one billion. Sandoz is
headquartered in Holzkirchen, in Germany's Greater Munich area.
For more information, please visit
http://www.sandoz.com
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*Humira® is a
registered trademark of AbbVie Biotechnology Ltd.
References
[1] Humira® Highlights of
Prescribing Information, 2002. Available at:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/125057s232lbl.pdf
. Last accessed December 2017.
[2] Blauvelt A et al. A randomized, double-blind, multicenter study
to compare the efficacy, safety, and immunogenicity of a proposed
adalimumab biosimilar (GP2017) with originator adalimumab Poster
#5224 presented at the 2017 American Academy of Dermatology (AAD)
Annual Meeting, 3-7 March 2017.
[3] Blauvelt A et.al. Long-Term Efficacy, Safety and Immunogenicity
Results from a Randomized, Double-Blind, Phase III Confirmatory
Efficacy and Safety Study Comparing GP2017, a Proposed Biosimilar,
with Reference Adalimumab [abstract]. Arthritis Rheumatol. 2017; 69
(suppl 10). American College of Rheumatology (ACR) Annual Meeting,
US, 3-9 November 2017.
[4] Jauch-Lembach J, et.al. Randomized, Double-Blind, Single-Dose,
Three-Arm Parallel Trial to Determine the Pharmacokinetics and
Safety of GP2017, EU- and US-Adalimumab in Healthy Male Subjects
[abstract]. Arthritis Rheumatol. 2017; 69 (suppl 10). American
College of Rheumatology (ACR) Annual Meeting, US, 3-9 November
2017.
[5] Sholtzhauer, T.L. (2014). Living with Rheumatoid Arthritis.
Available at:
https://books.google.co.uk/books?id=ouURBAAAQBAJ&lpg=PR17&dq=200.
Last accessed December 2017.
[6] Arthritis Foundation. What is Rheumatoid Arthritis? Available
at:
http://www.arthritis.org/about-arthritis/types/rheumatoid-arthritis/what-is-rheumatoid-arthritis.php.
Last accessed December 2017
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