Sandoz advances its biosimilars program with EMA acceptance of regulatory submission for biosimilar pegfilgrastim

Sandoz' late-stage biosimilar pipeline gains momentum with sustained investment - five of 10 planned regulatory filings achieved
Sandoz believes that the totality of evidence in its submission, including three pivotal clinical studies, demonstrates that the proposed biosimilar is highly similar to the reference product.
Sandoz is the European market leader in both the daily G-CSF class and for biosimilar filgrastim.

Holzkirchen, 11 February, 2016 - Sandoz, a Novartis company and the global leader in biosimilars, announced today that the European Medicines Agency (EMA) has accepted their Marketing Authorization Application (MAA) for its biosimilar to Amgen's EU-licensed Neulasta®* (pegfilgrastim) - a long-acting recombinant human granulocyte colony-stimulating factor (G-CSF). Sandoz is seeking approval for the same indication as the reference product.


Commenting on today's milestone, Richard Francis, Division Head and CEO Sandoz said, "Securing five major regulatory file acceptances in five months demonstrates substantial progress on our long-term biosimilars investment strategy. Further advancing our biosimilars pipeline is an important priority for us this year and we'll continue to invest significantly in bringing our pipeline to patients."


Pegfilgrastim is a prescription medicine used in cancer patients (except those with chronic myeloid leukemia and myelodysplastic syndromes) to help with some of the side effects of their treatment. It reduces the duration of neutropenia (low levels of neutrophils, a type of white blood cell that fights infections) and the incidence of febrile neutropenia (neutropenia with fever) that are a result of their chemotherapy treatment. The incidence of febrile neutropenia (FN) occurring with common chemotherapy regimens is 25 to 40% of treatment-naive patients.[1]


"Sandoz is the leading provider of daily G-CSF in Europe and the regulatory filing of our biosimilar pegfilgrastim further cements our commitment to patients undergoing cancer treatment" said Mark McCamish, M.D., Ph.D., and Head of Global Biopharmaceutical & Oncology Injectables Development at Sandoz.  "If approved, physicians in the EU will have another high-quality Sandoz biosimilar treatment option for patients needing granulocyte colony-stimulating factors" McCamish continued.

* Neulasta is a registered trademark of Amgen Inc.


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 - is expected to satisfy the regulatory requirements for demonstrating high similarity to the reference product and therefore justifies use of biosimilar pegfilgrastim in the reference product's indication.

Sandoz is committed to increasing patient access to high-quality, life-enhancing biosimilars. It is the pioneer and global market leader in biosimilars and currently markets three biosimilars. Sandoz has a leading pipeline with several biosimilars in late stage development, including assets in oncology. Pegfilgrastim was recently accepted by the FDA for regulatory filing, making today's announcement the fifth of 10 that the company plans to make over a three-year period (2015-2017). 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.

The foregoing release contains forward-looking statements that can be identified by words such as "pipeline," "momentum," "sustained," "planned," "believes," "proposed," "seeking," "long-term," "strategy," "priority," "we'll continue," "commitment," "will," "expected," "committed," "plans," "well-positioned," 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 Europe, 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 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 2015 sales of USD 9.2 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.


[1] Dale DC (2002) Colony-stimulating factors for the management of neutropenia in cancer patients. Drugs. 2002;62 Suppl 1:1-15.


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