FDA accepts Sandoz regulatory submission for a proposed biosimilar etanercept - Seite 2

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 Zarxio^TM (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 commercialization.

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Disclaimer
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.