Sandoz proposed biosimilars rituximab and etanercept recommended for approval in Europe*
(Thomson Reuters ONE) -
Novartis International AG /
Sandoz proposed biosimilars rituximab and etanercept recommended for approval in
Europe*
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The issuer is solely responsible for the content of this announcement.
* Sandoz receives positive CHMP opinions for biosimilars rituximab and
etanercept to treat immunological diseases. Biosimilar rituximab also
recommended to treat blood cancers
* Comprehensive data packages, confirming Sandoz biosimilars rituximab and
etanercept match their respective reference medicines, were the basis for
CHMP decisions
* Subject to EC** approval, Sandoz market leadership position extended as the
only company to have five approved biosimilars in Europe[1]
Holzkirchen, April 21, 2017 - Sandoz, a Novartis division, and the pioneer and
global leader in biosimilars, announced today that the Committee for Medicinal
Products for Human Use (CHMP) has adopted positive opinions, separately
recommending the approval of both Sandoz' biosimilar rituximab and biosimilar
etanercept in Europe, to treat the same indications as their respective
reference medicines.
"We are proud to help patients in Europe with blood cancers and immunological
diseases by improving their access to effective treatments through the potential
approval of not just one, but two new Sandoz biosimilar medicines," said Mark
Levick, MD PhD, Global Head of Development, Biopharmaceuticals, Sandoz. "Today's
recommendations from the CHMP will not only benefit patients, but they
demonstrate our leadership in biosimilars and the strength of the Sandoz and
Novartis immunology and oncology portfolios".
If approved, Sandoz biosimilar rituximab may be used in all indications of the
reference medicine, MabThera(®)***, which are non-Hodgkin's lymphoma -
follicular lymphoma and diffuse large B-cell lymphoma - chronic lymphocytic
leukemia, rheumatoid arthritis, granulomatosis with polyangiitis, and
microscopic polyangiitis.
If Sandoz biosimilar etanercept is approved, it may be used in all indications
of the reference medicine, Enbrel(®)****, which are rheumatoid arthritis, axial
spondyloarthritis (ankylosing spondylitis, non-radiographic axial
spondyloarthritis), plaque psoriasis, psoriatic arthritis, Juvenile idiopathic
arthritis and pediatric plaque psoriasis.
The CHMP recommendations were based on two comprehensive development programs in
which analytical, preclinical and clinical - including
pharmacokinetic/pharmacodynamic - data were generated. The programs demonstrated
biosimilarity of biosimilar rituximab and etanercept to their respective
reference medicines[2-8].
* Studies within the biosimilar rituximab development program included a
pharmacokinetic/pharmacodynamic (PK/PD) trial in rheumatoid arthritis
(ASSIST-RA)[7] and a Phase III confirmatory safety and efficacy study in
follicular lymphoma (ASSIST-FL)[8].
* The biosimilar etanercept development program included an innovative Phase
III confirmatory safety and efficacy study in moderate to severe plaque
psoriasis (EGALITY), which included three treatment switches between the
reference medicine and biosimilar etanercept[4].
Sandoz is committed to increasing patient access to high-quality, life-enhancing
biosimilars. It is the pioneer and global leader in biosimilars, and currently
markets three biosimilars worldwide. Sandoz has a leading biosimilar pipeline
and, in addition to biosimilar rituximab and etanercept (Erelzi(TM )approved in
2016 by the FDA), plans to launch three more biosimilars of major oncology and
immunology biologics across key geographies by 2020. As a division of the
Novartis Group, Sandoz is well-positioned to lead the biosimilars industry based
on its experience and capabilities in development, manufacturing and
commercialization.
Disclaimer
The foregoing release contains forward-looking statements that can be identified
by words such as "proposed," "recommended," "positive CHMP opinions," "positive
opinions," "recommending," "potential," "recommendations," "will," "may,"
"committed," "pipeline," "plans," "launch," "well-positioned," or similar terms,
or by express or implied discussions regarding potential marketing approvals or
labeling for biosimilar rituximab, biosimilar etanercept, or any of the other
products in the Sandoz biosimilar pipeline, or regarding potential future
revenues from biosimilar rituximab, biosimilar etanercept, and the other
products in the Sandoz biosimilar pipeline. You should not place undue reliance
on these statements. Such forward-looking statements are based on the current
beliefs and expectations of management 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 biosimilar rituximab,
biosimilar etanercept, or any of the other products in the Sandoz biosimilar
pipeline will be submitted or approved for sale in any market, or at any
particular time. Neither can there be any guarantee that, if approved,
biosimilar rituximab or biosimilar etanercept will be approved for all
indications included in the reference products' respective labels. Nor can there
be any guarantee that biosimilar rituximab, biosimilar etanercept, or any of the
other products in the Sandoz biosimilar pipeline will be commercially successful
in the future. In particular, management's expectations regarding biosimilar
rituximab, biosimilar etanercept, and such other Sandoz biosimilar pipeline
products could be affected by, among other things, regulatory actions or delays
or government regulation generally; the uncertainties inherent in research and
development, including clinical trial results and additional analysis of
existing clinical data; competition in general, including potential approval of
additional versions of biosimilar rituximab or biosimilar etanercept; global
trends toward health care cost containment, including government, payor and
general public pricing pressures; litigation outcomes, including intellectual
property disputes or other legal efforts to prevent or limit Sandoz from selling
biosimilar rituximab, biosimilar etanercept, or its other biosimilar products;
the particular prescribing preferences of physicians and patients; general
economic and industry conditions; 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.
* 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.
** European Commission
*** MabThera(®) is a registered trademark of F. Hoffmann-La Roche AG
**** Enbrel(®) is a registered trademark of Pfizer in Europe and Amgen in the
US.
References
[1] European Medicines Agency 2017. The European public assessment reports are
published on the European Medicines Agency website (cited 03 March 2017).
Available from:
http://www.ema.europa.eu/ema/index.jsp?curl=pages/medicines/landing/epar_search.
jsp&mid=WC0b01ac058001d124
[2] Visser J et al. Physicochemical and Functional Comparability Between the
Proposed Biosimilar Rituximab GP2013 and Originator Rituximab. BioDrugs.
2013;27:495-507.
[3] Da Silva A et al. Target-directed development and preclinical
characterization of the proposed biosimilar rituximab GP2013. Leuk Lymphoma.
2014;55:1609-1617.
[4] Griffiths C et al. The EGALITY study: a confirmatory, randomized, double-
blind study comparing the efficacy, safety and immunogenicity of GP2015, a
proposed etanercept biosimilar, vs. the originator product in patients with
moderate-to-severe chronic plaque-type psoriasis. Br J Dermatol 2016 [Epub ahead
of print].
[5] von Richter O et al. GP2015, a proposed etanercept biosimilar:
Pharmacokinetic similarity to its reference product and comparison of its auto-
injector device with pre-filled syringes. Br J Clin Pharmacol. 2016 Oct 27. doi:
10.1111/bcp.13170. [Epub ahead of print]
[6] Hofmann HP et al. Characterization and non-clinical assessment of the
proposed etanercept biosimilar GP2015 with originator etanercept (Enbrel(®)).
Exp Opin Biol Ther. 2016;16:1185-95.
[7] Smolen J et al. Pharmacokinetics, pharmacodynamics, safety and efficacy of
proposed rituximab biosimilar (GP2013) vs. EU-Approved rituximab (rtx) in
patients with rheumatoid arthritis: results from a randomized controlled trial
(GP13-201) over 52 weeks. EULAR congress, 8-11 June 2016, London UK: FRI0222.
[8] Jurczak W et al. A Phase III Efficacy and Safety Study of the Proposed
Rituximab Biosimilar GP2013 Versus Rituximab in Patients with Previously
Untreated Advanced Follicular Lymphoma ASH annual meeting, 3-6 December 2016,
San Diego, USA:1809.
# # #
For further information, contact:
Novartis Media Relations
Central media line: +41 61 324 2200
E-mail: media.relations(at)novartis.com
Eric Althoff Tara Lanigan
Novartis Global Media Relations Sandoz Global Communications
+41 61 324 7999 (direct) +49 172 8295 276
+41 79 593 4202 (mobile) tara.lanigan(at)sandoz.com
eric.althoff(at)novartis.com
Duncan Cantor Chris Lewis
Sandoz Global Communications Sandoz Global Communications
+49 170 650 6067 +49 8024 476 1906
duncan.cantor(at)sandoz.com chris.lewis(at)sandoz.com
Novartis Investor Relations
Central investor relations line: +41 61 324 7944
E-mail: investor.relations(at)novartis.com
Central North America
Samir Shah +41 61 324 7944 Richard Pulik +1 212 830 2448
Pierre-Michel Bringer +41 61 324 1065
Thomas Hungerbuehler +41 61 324 8425
Isabella Zinck +41 61 324 7188
Media release (PDF):
http://hugin.info/134323/R/2097440/793909.pdf
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Source: Novartis International AG via GlobeNewswire
Unternehmensinformation / Kurzprofil:
Datum: 21.04.2017 - 19:43 Uhr
Sprache: Deutsch
News-ID 537618
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