Sandoz strengthens its biosimilars portfolio with acquisition of Pfizer's biosimilar infliximab in EEA - Seite 2
Sandoz is committed to increasing patient access to high-quality biosimilars. It is the pioneer and global market leader in biosimilars and was the first to launch biosimilars in the United States, Europe and Japan. Sandoz has a leading biosimilar pipeline with programs in various stages of development and regulatory filing including biosimilars adalimumab and etanercept that, like infliximab, are anti-tumor necrosis factor alpha (TNF-alpha) medicines. The company plans to make 10 regulatory filings over a three year period (2015-2017) having already announced
* Pfizer retains commercialization and manufacturing rights to infliximab in all countries outside of the EEA.
five, which include biosimilar etanercept filed with both the EMA and the US Food and Drug Administration. As part of the Novartis Group, Sandoz is well-positioned to lead the biosimilars industry based on its deep 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 "plans," "investigational," "will," "commitment," "pipeline," "well-positioned to lead," or similar
terms, or by express or implied discussions regarding potential marketing approvals for PF-06438179, or regarding potential future revenues from PF-06438179. 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 PF-06438179 will be submitted or approved for sale in any market, or at any particular time. Nor can there be any guarantee that
PF-06438179 will be commercially successful in the future. In particular, management's expectations regarding PF-06438179 could be affected by, among other things, the uncertainties inherent in
research and development, including unexpected clinical trial results and additional analysis of existing clinical data; unexpected regulatory actions or delays or government regulation generally;
competition in general, including potential approval of additional versions of biosimilar infliximab; unexpected litigation outcomes, including intellectual property disputes or other legal efforts
to prevent or limit Sandoz from selling biosimilar infliximab; general economic and industry conditions; global trends toward health care cost containment, including ongoing pricing pressures;
unexpected safety issues; unexpected manufacturing or quality 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.