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Novartis AG. (11/18/15). "Press Release: Regulatory Submission for Sandoz’ Proposed Biosimilar Pegfilgrastim Accepted by the FDA". Holzkirchen.

Region Region United States (USA)
Organisations Organisation Sandoz International GmbH
  Group Novartis (Group)
  Organisation 2 FDA (US Food and Drug Administration)
  Group United States (govt)
Person Person McCamish, Mark (Novartis 201607 Head of Global Biopharma Development at Sandoz)
     


Sandoz continues to advance its biosimilars program:

Regulatory submission for Sandoz' proposed biosimilar pegfilgrastim accepted by the FDA

> Sandoz demonstrates commitment to oncology by seeking approval for its proposed biosimilar pegfilgrastim.

> Sandoz believes that the totality of evidence in its submission, including three pivotal clinical studies, will demonstrate that the proposed biosimilar is highly similar to the reference product.

> Proposed biosimilar pegfilgrastim filing is the second of ten regulatory filings planned over the next three years.


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 Neulasta® (pegfilgrastim)* - a recombinant human granulocyte colony-stimulating factor (G-CSF).

Sandoz is seeking approval for the same indication as the reference product. Pegfilgrastim is a prescription medicine used to help reduce the chance of infection due to a low white blood cell count, in patients with cancer (non-myeloid) who receive chemotherapy that can cause fever and a low blood cell count (febrile neutropenia).In the US, the incidence of febrile neutropenia is estimated to be more than 60,000 a year, accounting for nearly eight cases per 1,000 cancer patients.[1] Approximately 1.6 million people per year in the US develop non-myeloid cancer.[2]

"The FDA's acceptance of our regulatory submission for biosimilar pegfilgrastim - our third biosimilar filed in the US - demonstrates our commitment to expanding patient access to biologics in the US" said Mark McCamish, M.D., Ph.D., and Head of Global Biopharmaceutical & Oncology Injectables Development at Sandoz. "If approved, physicians will have another high-quality Sandoz treatment option for patients needing granulocyte colony-stimulating factors" McCamish continued.

Sandoz believes that the totality of evidence in its submission, including three pivotal clinical trials - one pharmacokinetic and pharmacodynamic study in healthy volunteers and two comparative efficacy and safety studies in breast cancer patients - will demonstrate that the proposed biosimilar is highly similar to the reference product and therefore justifies use of biosimilar pegfilgrastim in the reference product's indication.

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. On 3 September, 2015 Sandoz launched the first biosimilar in the United States and recently had its regulatory submission for proposed biosimilar etanercept accepted by the FDA. 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 planned regulatory filings over the next three years. As part of the Novartis Group, Sandoz is well-positioned to lead the biosimilars industry based on its experience and capabilities in development, manufacturing and commercialization.


* Neulasta is a registered trademark of Amgen Inc.


Disclaimer

The foregoing release contains forward-looking statements that can be identified by words such as "proposed," "commitment," "seeking," "believes," "will," "planned," "potentially," "pipeline," "plans," or similar terms, or by express or implied discussions regarding potential marketing approvals for biosimilar pegfilgrastim, or regarding potential future revenues from biosimilar pegfilgrastim. 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 pegfilgrastim will be approved for sale in the United States, or at any particular time. Neither can there be any guarantee that biosimilar pegfilgrastim will be submitted or approved for sale in any additional markets, or at any particular time. Nor can there be any guarantee that biosimilar pegfilgrastim will be commercially successful in the future. In particular, management's expectations regarding biosimilar pegfilgrastim 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 pegfilgrastim; 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 pegfilgrastim; 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 and biosimilars, 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 portfolio comprises approximately 1,100 molecules, which accounted for 2014 sales of USD 9.6 billion. Sandoz is headquartered in Holzkirchen, in Germany's Greater Munich area. The company holds leading global positions in biosimilars as well as in generic anti-infectives, ophthalmics and transplantation medicines.


References

[1] Caggiano V, Weiss RV, Rickert TS, Linde-Zwirble WT. Incidence, cost, and mortality of neutropenia hospitalization associated with chemotherapy. Cancer. 2005;103(9):1916

[2] American Cancer Society. Cancer Facts & Figures 2015. http://www.cancer.org/acs/groups/content/@editorial/documents/document/acspc-044552.pdf (link is external) (Last accessed 19 October 2015)


# # #


For further information:

Eric Althoff
Novartis Global Media Relations
+41-61-324-7999
+41-79-593-4202
eric.althoff@novartis.com

Sreejit Mohan
Sandoz Global Communications+49 (0) 162 429 7971
sreejit.mohan@sandoz.com

Leslie Pott
Sandoz US Communications
+1-609-627-5287
+1-201-354-0279
leslie.pott@sandoz.com

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

e-mail: investor.relations@novartis.com

   
Record changed: 2017-04-02

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