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Novartis International AG: FDA accepts Sandoz regulatory submission for a proposed biosimilar etanercept

Novartis International AG / FDA accepts Sandoz regulatory submission for a
proposed biosimilar etanercept. Processed and transmitted by NASDAQ OMX
Corporate Solutions. The issuer is solely responsible for the content of this
* Etanercept is an anti-TNF medicine used to treat a range of immunological
diseases including rheumatoid arthritis and psoriasis.
* Sandoz is seeking approval for all indications included in the reference
product's label.
* Sandoz believes that the totality of evidence in its submission, including
two pivotal clinical studies, will demonstrate that the proposed biosimilar
is essentially the same as the reference product.

Holzkirchen, October 2, 2015
- Sandoz, a Novartis company and the global leader in biosimilars, announced
today that the US Food and Drug Administration (FDA) has accepted its
Biologics License Application (BLA) under the 351 (k) pathway for its
proposed biosimilar to Amgen's US-licensed Enbrel®*(etanercept) - a tumor
necrosis factor alpha (TNF-alpha) inhibitor. Sandoz is seeking approval for
all indications included in the label of the reference product which is used
to treat a range of autoimmune diseases including rheumatoid arthritis and
psoriasis affecting approx. 1.3 million[1] and 7.5 million[2]people
(respectively) in the US.

Mark McCamish, M.D., Ph.D., and Head of Global Biopharmaceutical&Oncology
Injectables Development at Sandoz said "anti-TNFs will continue to play a
leading role in immunology treatment and the acceptance of our regulatory
submission by the FDA today is a significant step towards increasing patient
access to these life-changing medicines." McCamish continued "we believe we
are the first company to receive FDA file acceptance of a biosimilar version
of etanercept."

This is the second BLA submission by Sandoz using the 351(k) biosimilar
pathway. The BLA consists of a comprehensive data package that includes data
from analytical, functional, pre-clinical and clinical studies. Sandoz
believes that the two pivotal clinical studies; a pharmacokinetic (PK) study
in healthy volunteers (HVs) and a confirmatory safety and efficacy study in
patients with chronic plaque-type psoriasis (EGALITY), will provide
confirmation of similarity to the reference product established in prior
analytical comparability investigations.

Sandoz has an unwavering commitment to increasing patient access to
high-quality, life-enhancing biosimilars. It is the pioneer and global market
leader and currently markets three biosimilars. Sandoz recently launched
ZarxioTM(filgrastim-sndz) - the first biosimilar in the United States,
signaling a shift toward more competition and affordability in the healthcare
system. Sandoz has a leading pipeline with several biosimilars across the
various stages of development including five programs in Phase III clinical
trials or registration preparation. The company plans to make ten regulatory
submissions in the next three years. As part of the Novartis Group, Sandoz
is uniquely positioned to lead the biosimilars industry based on its
experience and capabilities in development, manufacturing and



The foregoing release contains forward-looking statements that can be
identified by words such as "proposed," "seeking," "will," "step towards,"
"believe," "commitment," "signaling," "pipeline," "plans," or similar terms,
or by express or implied discussions regarding potential marketing approvals
for biosimilar etanercept, or regarding potential future revenues from
biosimilar etanercept. 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
etanercept will be approved for sale in the United States, or at any
particular time. Neither can there be any guarantee that biosimilar
etanercept will be submitted or approved for sale in any additional markets,
or at any particular time. Nor can there be any guarantee that biosimilar
etanercept will be commercially successful in the future. In particular,
management's expectations regarding biosimilar etanercept could be affected
by, among other things, unexpected regulatory actions or delays or government
regulation generally; the uncertainties inherent in research and development,
including unexpected clinical trial results and additional analysis of
existing clinical data; competition in general, including potential approval
of additional versions of biosimilar etanercept; global trends toward health
care cost containment, including government, industry and general public
pricing pressures; unexpected litigation outcomes, including intellectual
property disputes or other legal efforts to prevent or limit Sandoz from
selling biosimilar etanercept; the particular prescribing preferences of
physicians and patients; unexpected safety issues; unexpected manufacturing
or quality issues; general economic and industry conditions, 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, a Novartis company, is a global leader in generic pharmaceuticals,
driving sustainable access to high-quality healthcare. Sandoz employs more
than 26,000 people worldwide and supplies a broad range of affordable,
primarily off-patent products to patients and customers around the globe.
The Sandoz global portfolio comprises approximately 1,100 molecules, which
accounted for 2014 sales of USD 9.6 billion. Sandoz holds the global #1
position in biosimilars as well as in generic anti-infectives, ophthalmics
and transplantation medicines.
Nearly half of Sandoz's portfolio is in differentiated products - products
that are scientifically more difficult to develop and manufacture than
standard generics.

In addition to strong organic growth since consolidating its generics
businesses under the Sandoz brand name in 2003, Sandoz has consistently
driven growth in selected geographies and differentiated product areas
through a series of targeted acquisitions.

* Enbrel is a registered trademark of Amgen Inc.


[1] American College of
accessed 13 September 2015)

[2] National Psoriasis
Association. accessed 13
September 2015)

# # #

For further information:

| |
| Eric Althoff Sreejit Mohan |
| |
|Novartis Global Media Relations Sandoz Global Communications |
|+41-61-324-7999 +49 (0) 162 429 7971 |
|+41-79-593-4202 |
| |
Leslie Pott

Sandoz US Communications

Novartis Investor Relations

| Central phone: +41 61 324 7944 North America: |
| Samir Shah +41 61 324 7944 Richard Pulik +1 212 830 2448 |
| Pierre-Michel Bringer +41 61 324 1065 Sloan Pavsner +1 212 830 2417 |
| Thomas Hungerbuehler +41 61 324 8425 |
| Isabella Zinck +41 61 324 7188 |
| |
| |
©2015 Sandoz Inc. All rights reserved.

Media release (PDF)


This announcement is distributed by NASDAQ OMX Corporate Solutions on behalf of NASDAQ OMX 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


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