Sandoz receives approval in Europe for Rixathon® (biosimilar rituximab) to treat blood cancers and immunological diseases - Seite 2

About Rixathon
EC approval was based on a comprehensive development program, including analytical, preclinical, and clinical data, demonstrating biosimilarity of Rixathon to the reference medicine, MabThera^®. Clinical studies included:

• The ASSIST-RA study, which demonstrated that Rixathon and its reference medicine have equivalent PK/PD profiles, with no clinically meaningful differences in safety, tolerability, or immunogenicity in patients with rheumatoid arthritis[6].
• The ASSIST-FL study; a Phase III confirmatory efficacy and safety study. The study met its primary endpoint of equivalence in overall response rate (ORR) between Rixathon and the reference medicine after six months. Results also confirmed the comparable safety profile of the two medicines[7].

Disclaimer
The foregoing release contains forward-looking statements that can be identified by words such as "expected," "committed," "will," "launches," "plan," "in the next four years," "pipeline," "plans," "launch," "by 2020," "well-positioned," or similar terms, or by express or implied discussions regarding potential additional marketing approvals or labeling for biosimilar rituximab, or any of the other potential products in the Sandoz biosimilar pipeline, or regarding potential future revenues from biosimilar rituximab, the other marketed products in the Sandoz biosimilar portfolio, and the potential products in the Sandoz biosimilar pipeline. 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 rituximab or any of the other marketed products in the Sandoz biosimilar portfolio will be submitted or approved for sale in any additional markets, or at any particular time. Neither can there be any guarantee that any of the potential products in the Sandoz biosimilar pipeline will be submitted or approved for sale in any market, or at any particular time. Nor can there be any guarantee that if approved, any of the potential products in the Sandoz biosimilar pipeline will be approved for any or all of the indications in the respective reference product's label. Neither can there be any guarantee that biosimilar rituximab, the other marketed products in the Sandoz biosimilar portfolio, or the potential products in the Sandoz biosimilar pipeline will be commercially successful in the future. In particular, management's expectations regarding biosimilar rituximab and such other biosimilar candidates and marketed products could be affected by, among other things, regulatory actions or delays or government regulation generally; the uncertainties inherent in research and development, including clinical trial results and additional analysis of existing clinical data; competition in general, including potential approval of additional versions of biosimilar rituximab; global trends toward health care cost containment, including government, payor and general public pricing and reimbursement pressures; litigation outcomes, including intellectual property disputes or other legal efforts to prevent or limit Sandoz from selling its biosimilar products; the particular prescribing preferences of physicians and patients; general economic and industry conditions; safety, quality or 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.