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 The leading web portal for pharmacy resources, news, education and careers November 20, 2017
Pharmacy Choice - Pharmaceutical News - GNW-News: Sandoz proposed biosimilar rituximab accepted for review by the FDA (english) - November 20, 2017

Pharmacy News Article

 9/12/17 - GNW-News: Sandoz proposed biosimilar rituximab accepted for review by the FDA (english)

Sandoz proposed biosimilar rituximab accepted for review by the FDA

Novartis International AG / Sandoz proposed biosimilar rituximab accepted for review by the FDA . Processed and transmitted by Nasdaq Corporate Solutions. The issuer is solely responsible for the content of this announcement.

* Rituximab is indicated to treat blood cancers and immunological diseases

such as rheumatoid arthritis[1]

* Sandoz believes the comprehensive data package submitted to the FDA for

review confirms that our biosimilar rituximab matches the reference medicine

in terms of safety, efficacy and quality

* The global leader in biosimilars, Sandoz has five biosimilars approved

worldwide including biosimilar rituximab, which was approved in Europe* in

June 2017[2]

Holzkirchen, September 12, 2017 - Sandoz, a Novartis Division, and the pioneer
and 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 a proposed biosimilar to the reference medicine,
Rituxan()(**) (rituximab).

Rituxan()(**) is used to treat blood cancers including 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.

"The cost of treating cancer in the US is a major concern for many patients and
their families as well as for the healthcare system[3]" said Mark Levick, MD
PhD, Global Head of Development, Biopharmaceuticals. "With the FDA acceptance of
our regulatory submission for proposed biosimilar rituximab, we plan to deliver
patients a high-quality Sandoz biosimilar that, following approval, could help
drive healthcare savings and increase competition, while freeing up resources
for and supporting patient access in other areas of cancer care including
innovative therapies."

The BLA consists of a comprehensive data package that includes analytical,
preclinical and clinical data. Clinical studies included a
pharmacokinetic/pharmacodynamic (PK/PD) trial in rheumatoid arthritis (ASSIST-
RA)[4], and a Phase III confirmatory safety and efficacy study in follicular
lymphoma (ASSIST-FL)[5]. Sandoz believes these data provide confirmation that
the proposed biosimilar matches the reference medicine in terms of safety,
efficacy and quality.

Sandoz is committed to increasing patient access to high-quality biosimilars. As
the pioneer and global leader in biosimilars, Sandoz has five biosimilars
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.
This includes biosimilar rituximab, which was approved by the European
Commission for use in Europe in June 2017 (marketed as Rixathon()).

Sandoz is well positioned to continue leading the biosimilars industry based on
its 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, Sandoz benefits strongly from this unique blend of experience and
expertise in many different market environments.

Sandoz also continues to champion policy and legislation that enables patients
and the healthcare system to benefit from biosimilars. This was demonstrated by
the recent US Supreme Court unanimous positive decision related to the Notice of
Commercial Marketing (NCM). The Supreme Court ruled that NCM can be provided
before FDA approval, accelerating patient access to future US biosimilars by
180 days. The Court also provided additional clarity on how the "patent dance,"
the process by which biosimilar manufacturers may provide confidential and
proprietary information to the manufacturer of the reference medicine in the
patent exchange process, will function.


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.

Sandoz is on Twitter. Sign up to follow @Sandoz-global at

Follow our blog at


  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 (0) 172 8295 276
  +41 79 593 4202 (mobile)

  Chris Lewis                       Michelle Bauman

Sandoz Global Communications Sandoz US Communications

+49 8924 476 1906 (direct) +1 609 720 6699

+49 174 244 9501 (mobile) +1 973 714 8043  

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

* 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.
(**)Rituxan() is a trademark of BIOGEN MA INC.


[1] Rituximab (marketed as Rituxan) Information. U.S. Food and Drug
Administration. Available from:
informationforpatientsandproviders/ucm109106.htm [Accessed: August 2017].
[2] European Medicines Agency. Rixathon() Summary of Product Characteristics.
Available from:
-Product-Information/human/003903/WC500232460.pdf. [Accessed: August 2017].
[3] S Ramsey, et al. Washington State cancer patients found to be at greater
risk for bankruptcy than people without a cancer diagnosis Health Aff (Millwood)
32: 1143-1152, 2013.
[4] 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.
[5] 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.

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

Copyright dpa-AFX.

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