-
Sandoz strengthens position as
global leader in biosimilars with new immunology data from four
clinical studies for proposed biosimilars adalimumab and
rituximab
-
Efficacy and safety of
biosimilar adalimumab and safety of biosimilar rituximab match
reference medicines in multiple-switching and retreatment study
respectively
-
Sandoz biosimilar adalimumab is
under EMA review, while EC-approved Sandoz biosimilar rituximab is
under review by the FDA
Holzkirchen, November 14,
2017- Sandoz, a Novartis division and the global leader in
biosimilars, today announces data from four clinical studies
comparing its proposed biosimilar adalimumab and biosimilar
rituximab with their reference medicines, Humira®* and
MabThera®/Rituxan®**
respectively[1]-[4].
Studies included two innovative trials involving
switching and two pharmacokinetic (PK) and pharmacodynamic (PD)
studies. The results were presented at the American College of
Rheumatology (ACR) Annual Meeting in San Diego, US.
Innovative studies involving
switching:
-
A Phase III confirmatory efficacy and safety
study met its primary endpoint in the proportion of patients who
achieved a 75% improvement at Week 16, as measured by the Psoriasis
Area and Severity Index (PASI)[5]. Further the impact of switching
between Sandoz biosimilar adalimumab and its reference medicine in
patients with moderate-to-severe chronic plaque psoriasis was
assessed. This innovative study design included continuous and
'switch' treatment arms. The study confirmed no clinically
meaningful differences in efficacy, safety and immunogenicity
between patients who continuously received biosimilar adalimumab,
those who continuously received the reference medicine and those
who switched between biosimilar adalimumab and reference medicine
on multiple occasions[1].
-
A Phase III study evaluated rituximab
retreatment in patients with rheumatoid arthritis (RA), who already
had received reference rituximab for treatment of RA in the past.
The study demonstrated that Sandoz biosimilar rituximab and the
reference medicines match in terms of safety and immunogenicity for
patients who switched from the reference medicine to biosimilar
rituximab and for those who continued treatment with the reference
medicine[2].
"Healthcare systems have a significant opportunity
to deliver much-needed savings by switching to high-quality
biosimilars," said Mark Levick, MD PhD, Global Head of Development,
Biopharmaceuticals, Sandoz. "Not only does the data presented
demonstrate that our biosimilar adalimumab and biosimilar rituximab
are important biologic alternatives for patients, but that
physicians can switch to our biosimilars with confidence."
PK and PD data demonstrating
equivalence:
-
The Phase I PK study met its primary endpoint as
bioequivalence was demonstrated between the biosimilar adalimumab
and the reference medicine. The study demonstrated that Sandoz
biosimilar adalimumab matched the reference adalimumab in terms of
safety, tolerability and immunogenicity[3].
-
The confirmatory PK and PD study in patients
with RA met its primary endpoint by demonstrating PK bioequivalence
and PD equivalence of biosimilar rituximab and the reference
medicine. Study results further demonstrated the medicines have
matching efficacy, safety and immunogenicity profiles[4].
Sandoz is committed to increasing patient access
to high-quality biosimilars. We are the global leader in
biosimilars, with five biosimilars currently marketed in various
countries, as well as a leading global pipeline. Sandoz biosimilar
rituximab, marketed as Rixathon®, was approved
by the European Commission (EC)[6] in June 2017 and is currently
under review by the US Food and Drug Administration (FDA). Sandoz
biosimilar adalimumab is currently being reviewed by the European
Medicines Agency (EMA).
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.
Sandoz is on Twitter. Sign up to follow
@Sandoz_global at http://twitter.com/Sandoz_Global
Follow our blog at www.sandoz.com/makingaccesshappen
* Humira® is a
registered trademark of AbbVie Biotechnology Ltd.
** MabThera® is a
registered trademark of F. Hoffmann-La Roche AG /
Rituxan® is a
registered trademark of BIOGEN MA INC (marketed as
MabThera® in the EU and
Rituxan® in the
US).
*** Sandoz biosimilar rituximab has also been approved in Europe
(European Economic Area (EEA). The European Economic Area (EEA)
provides for the free movement of persons, goods, services and
capital within the internal market of the European Union (EU)
between its 28 member states, as well as three of the four member
states of the European Free Trade Association (EFTA): Iceland,
Liechtenstein, and Norway) as Riximyo® under a
duplicate marketing authorization[6].
References
[1] 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). ACR Meeting Abstracts -
http://acrabstracts.org/abstract/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-adalimum/
[Accessed October 2017].
[2] Tony HP,et.al. Comparison of Switching from the
Originator Rituximab to the Biosimilar Rituximab GP2013 or
Re-treatment with the Originator Rituximab in Patients with Active
Rheumatoid Arthritis: Safety and Immunogenicity Results from a
Multicenter, Randomized, Double-Blind Study [abstract]. Arthritis
Rheumatol. 2017; 69 (suppl 10).
http://acrabstracts.org/abstract/comparison-of-switching-from-the-originator-rituximab-to-the-biosimilar-rituximab-gp2013-or-re%E2%80%91treatment-with-the-originator-rituximab-in-patients-with-active-rheumatoid-arthritis-safety-and/
[Accessed October 2017].
[3] 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).
http://acrabstracts.org/abstract/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/
[Accessed October 2017].
[4] Smolen JS, et.al. A Randomized, Double Blind Trial
over 52 Weeks to Demonstrate Bioequivalence of GP2013 and Reference
Rituximab in Patients with Rheumatoid Arthritis [abstract].
Arthritis Rheumatol. 2017; 69 (suppl 10).
http://acrabstracts.org/abstract/a-randomized-double-blind-trial-over-52-weeks-to-demonstrate-bioequivalence-of-gp2013-and-reference-rituximab-in-patients-with-rheumatoid-arthritis/
[Accessed October 2017].
[5] 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.
[6] European Medicines Agency. Riximyo®
Summary of Product Characteristics.
###
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