FDA accepts Sandoz application for biosimilar filgrastim - Seite 2

[1] Includes products approved in North America, Europe, Japan and Australia

Disclaimer
This press release contains forward-looking statements that can be identified by words such as "first step," "poised," "pipeline," or similar terms, or by express or implied discussions regarding potential marketing approval for biosimilar filgrastim, or regarding potential future revenues from biosimilar filgrastim. 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 filgrastim will be approved for sale in any market, or at any particular time. Nor can there be any guarantee that biosimilar filgrastim will be commercially successful in the future. In particular, management's expectations regarding biosimilar filgrastim 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; the company's ability to obtain or maintain proprietary intellectual property protection; general economic and industry conditions; global trends toward health care cost containment, including ongoing pricing pressures; unexpected 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, the generic pharmaceuticals division of Novartis, is a global leader in the generic pharmaceutical sector.  Sandoz employs over 26,500 employees and its products are available in more than 160 countries, offering a broad range of high-quality, affordable products that are no longer protected by patents.  With USD 9.2 billion in sales in 2013, Sandoz has a portfolio of approximately 1,100 molecules, and holds the #1 position globally in biosimilars as well as in generic injectables, ophthalmics, dermatology and antibiotics, complemented by leading positions in the cardiovascular, metabolism, central nervous system, pain, gastrointestinal, respiratory, and hormonal therapeutic areas.  Sandoz develops, produces, and markets these medicines, as well as active pharmaceutical and biotechnological substances.  Nearly half of Sandoz's portfolio is in differentiated products, which are defined as products that are more difficult to scientifically develop and manufacture than standard generics.