Sandoz receives approval in Europe for Rixathon® (biosimilar rituximab) to treat blood cancers and immunological diseases|
Novartis International AG /
Sandoz receives approval in Europe for Rixathon® (biosimilar rituximab) to treat
blood cancers and immunological diseases
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* European Commission approves Sandoz Rixathon(®) to treat blood cancers and
* Approval expected to broaden patient access to biologics and enable budget-
constrained healthcare systems to reallocate resources to other healthcare
* Sandoz now has four biosimilars approved in Europe - more than any other
Holzkirchen, June 19, 2017 - Sandoz, a Novartis division, and the pioneer and
global leader in biosimilars, announced today that the European Commission (EC)
has approved Rixathon(®) (biosimilar rituximab*) for use in Europe**. Rixathon
is approved for use in all indications of the reference medicine, MabThera(®***
"Today's approval of Rixathon represents a big win for patients in Europe with
blood cancers or immunological diseases because it enables increased access to
biologics. It also allows healthcare systems to redeploy resources to other
areas of high need, particularly innovative therapies" said Carol Lynch, Global
Head, Biopharmaceuticals, Sandoz. "Sandoz is committed to increasing patient
access to biologic medicines, and Rixathon will be one of the five major
launches we plan in the next four years. We have worked with care and passion
towards this approval, and now is the time when we are bringing this medicine to
healthcare professional and patients in Europe."
Rixathon is approved for non-Hodgkin's lymphoma (follicular lymphoma and diffuse
large B-cell lymphoma) and chronic lymphocytic leukemia, as well as
immunological diseases such as rheumatoid arthritis, granulomatosis with
polyangiitis, and microscopic polyangiitis.
The EC approval was based on a comprehensive development program generating
analytical, preclinical, and clinical - including
pharmacokinetic/pharmacodynamic (PK/PD) - data. The program demonstrated
Rixathon matches its reference medicine in terms of safety, efficacy, and
Sandoz is committed to increasing patient access to high-quality, life-enhancing
biosimilar medicines. It is the pioneer and global leader in biosimilars, and
now has four biosimilar medicines approved in Europe. Sandoz has a leading
biosimilar pipeline, and plans to obtain approval for and launch four more
biosimilars of major oncology and immunology biologics by 2020. 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
EC approval was based on a comprehensive development program, including
analytical, preclinical, and clinical data, demonstrating biosimilarity of
Rixathon to the reference medicine, MabThera(®). Clinical studies included:
* The ASSIST-RA study, which demonstrated that Rixathon and its reference
medicine have equivalent PK/PD profiles, with no clinically meaningful
differences in safety, tolerability, or immunogenicity in patients with
* The ASSIST-FL study; a Phase III confirmatory efficacy and safety study. The
study met its primary endpoint of equivalence in overall response rate (ORR)
between Rixathon and the reference medicine after six months. Results also
confirmed the comparable safety profile of the two medicines.
The foregoing release contains forward-looking statements that can be identified
by words such as "expected," "committed," "will," "launches," "plan," "in the
next four years," "pipeline," "plans," "launch," "by 2020," "well-positioned,"
or similar terms, or by express or implied discussions regarding potential
additional marketing approvals or labeling for biosimilar rituximab, or any of
the other potential products in the Sandoz biosimilar pipeline, or regarding
potential future revenues from biosimilar rituximab, the other marketed products
in the Sandoz biosimilar portfolio, and the potential 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
or any of the other marketed products in the Sandoz biosimilar portfolio will be
submitted or approved for sale in any additional markets, or at any particular
time. Neither can there be any guarantee that any of the potential products in
the Sandoz biosimilar pipeline will be submitted or approved for sale in any
market, or at any particular time. Nor can there be any guarantee that if
approved, any of the potential products in the Sandoz biosimilar pipeline will
be approved for any or all of the indications in the respective reference
product's label. Neither can there be any guarantee that biosimilar rituximab,
the other marketed products in the Sandoz biosimilar portfolio, or the potential
products in the Sandoz biosimilar pipeline will be commercially successful in
the future. In particular, management's expectations regarding biosimilar
rituximab and such other biosimilar candidates and marketed 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; 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
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
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 biosimilar rituximab has also been approved in the EU as Riximyo(®)
under a duplicate marketing authorization.
(**)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.
(***)MabThera® is a registered trademark of F. Hoffmann-La Roche AG.
 European Medicines Agency. European public assessment reports. Available at:
jsp&mid=WC0b01ac058001d124. [Accessed: June 2017].
 European Medicines Agency. Rixathon(®) Summary of Product Characteristics.
 European Medicines Agency. MabThera(®) Summary of Product Characteristics.
Available at: https://www.medicines.org.uk/emc/medicine/2570. [Accessed: June
 Visser J, et al. Physicochemical and Functional Comparability Between the
Proposed Biosimilar Rituximab GP2013 and Originator Rituximab. BioDrugs.
2013; 27: 495-507.
 Da Silva A, et al. Target-directed development and preclinical
characterization of the proposed biosimilar rituximab GP2013. Leuk Lymphoma.
2014; 55: 1609-1617.
 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.
 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.
 European Medicines Agency. Riximyo(®) Summary of Product Characteristics.
# # #
For further information, contact:
Novartis Media Relations
Central media line: +41 61 324 2200
Eric Althoff Tara Lanigan
Novartis Global Media Relations Sandoz Global Communications
+41 61 324 7999 (direct) +49 172 8295 276
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Sandoz Global Communications
+49 8024 476 1906
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
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Thomas Hungerbuehler +41 61 324 8425
Isabella Zinck +41 61 324 7188
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Source: Novartis International AG via GlobeNewswire
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