New data reinforces clinical basis for switching to Sandoz biosimilar medicines|
Novartis International AG /
New data reinforces clinical basis for switching to Sandoz biosimilar medicines
. Processed and transmitted by Nasdaq Corporate Solutions.
The issuer is solely responsible for the content of this announcement.
* 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
* 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-.
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
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). 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.
* 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
"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.
* 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.
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) 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.
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.
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
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
 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 -
[Accessed October 2017].
 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-
rheumatoid-arthritis-safety-and/ [Accessed October 2017].
 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-
 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).
with-rheumatoid-arthritis/ [Accessed October 2017].
 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.
 European Medicines Agency. Riximyo(® )Summary of Product Characteristics.
For further information, contact:
Novartis Media Relations
Central media line
+41 61 324 2200
Eric Althoff Michelle Bauman
Novartis Global Media Relations Sandoz US Communications
+41 61 324 7999 (direct) ++1 609 720 6699
+41 79 593 4202 (mobile) ++1 973 714 8043
Sandoz Global Communications
+49 8924 476 1906 (direct)
+49 174 244 9501 (mobile)
Novartis Investor Relations
Central investor relations line
+41 61 324 7944
Central North America
Samir Shah +41 61 324 7944 Richard Pulik +1 212 830 2448
Pierre-Michel Bringer +41 61 324 1065 Cory Twining +1 212 830 2417
Thomas Hungerbuehler +41 61 324 8425
Isabella Zinck +41 61 324 7188
Media release (PDF):
This announcement is distributed by Nasdaq Corporate Solutions on behalf of Nasdaq Corporate Solutions clients.
The issuer of this announcement warrants that they are solely responsible for the content, accuracy and originality of the information contained therein.
Source: Novartis International AG via GlobeNewswire
durchschnittliche Punktzahl: 0|