-
51-week clinical study confirms
that Sandoz proposed biosimilar adalimumab matches reference
medicine Humira®* safety and
efficacy profile[1]
-
Sandoz proposed biosimilar
adalimumab is currently under review by the European Medicines
Agency for the treatment of several immunological
diseases
-
Sandoz expects that approval of
biosimilar adalimumab would further improve access to treatment for
people living with immunological diseases
Holzkirchen, September 14,
2017 - Sandoz, a Novartis division and the pioneer and global
leader in biosimilars, today announces new data on its proposed
biosimilar adalimumab.
Data from a long-term study of patients
continuously treated with the proposed biosimilar or the reference
medicine show that efficacy and safety profiles of the two
medicines match throughout 51 weeks of treatment in patients with
moderate-to-severe chronic plaque psoriasis[1]. Results were
presented at the 26th Congress of
the European Academy of Dermatology and Venereology (EADV) in
Geneva, Switzerland.
"Patient access to often critical and expensive
biologic medicines is one of the key challenges facing healthcare
systems in developed economies today," said Mark Levick MD, PhD,
Global Head of Development, Biopharmaceuticals, Sandoz.
He added: "Biosimilars are fundamentally changing
the ability of healthcare systems to address this challenge. This
clinical data supports the safety and efficacy of our proposed
biosimilar adalimumab and offers a real alternative for
patients living with immunological diseases."
Sandoz is committed to increasing patient access
to high-quality biosimilars. We are the pioneer and global leader
in biosimilars, with five biosimilars currently marketed worldwide,
as well as a leading global pipeline. We plan to launch a total of
five major oncology and immunology biosimilars between 2017 and
2020, including adalimumab, which is currently being reviewed by
the European Medicines Agency.
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.
About the study
ADACCESS (NCT02016105) is a Phase III confirmatory randomized,
double-blind, controlled, 51-week study to compare efficacy and
safety between Sandoz biosimilar adalimumab and the reference
medicine. The study consists of three treatment periods. During the
first 17-week treatment period, eligible patients with active, but
clinically stable, moderate-to-severe chronic plaque psoriasis were
randomized to receive either biosimilar adalimumab or its reference
medicine. In the second period, patients were re-randomized into
four groups; the first two groups continued with their originally
assigned treatment and the other two switched to alternating
treatment every six weeks until Week 35. In the third period,
patients received their initially assigned treatment up to Week
51[1].
The Phase III confirmatory study demonstrates that
Sandoz biosimilar adalimumab matches the reference medicine in
terms of efficacy and safety up to Week 51. Psoriasis Area and
Severity Index 75 (PASI 75) response rates for patients who
received biosimilar adalimumab continuously throughout the study
were 75.2% at Week 17 and 84.5% at Week 51, compared with 67.8% at
Week 17 and 79.6% at Week 51 for patients who received continuous
treatment with the reference medicine[1]. PASI 75 response
represents an improvement of at least 75% in the severity of a
patient's psoriasis. Investigator's Global Assessment (IGA)
response rates were also similar between the two groups in the
study throughout the 51 weeks. There were no clinically relevant
differences in adverse events between the two treatment groups, and
the immunogenicity profiles were similar[1].
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.
*Humira® is a
registered trademark of AbbVie Biotechnology Ltd.
References
[1] Blauvelt A et al. A phase III confirmatory study comparing
GP2017 with reference adalimumab in patients with
moderate-to-severe chronic plaque psoriasis: 51 week results from
the ADACCESS study. Poster #P0405 presented at the 26th Congress of
the European Academy of Dermatology and Venereology (EADV), 13-17
September 2017.
# # #
For further information,
contact:
Novartis Media Relations Central
media line: +41 61 324 2200
media.relations@novartis.com
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Lanigan
Sandoz Global Communications
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