Sandoz proposed biosimilar pegfilgrastim accepted by EMA for regulatory review

• Comprehensive data package demonstrates that Sandoz biosimilar pegfilgrastim matches the reference biologic in terms of safety, efficacy and quality
• Pegfilgrastim is a long-acting version of oncology medicine filgrastim -- Sandoz is the European market leader for filgrastim  
• Sandoz is the global leader in biosimilars, with five biosimilars marketed worldwide and a leading global pipeline, including three biosimilars currently under EMA review

Holzkirchen, October 27, 2017 – Sandoz, a Novartis Division, and the global leader in biosimilars, announced today that its biosimilar to EU-authorized Neulasta^®* (pegfilgrastim) has been accepted by the European Medicines Agency (EMA) for regulatory review.

Pegfilgrastim is a long-acting formulation of filgrastim (granulocyte colony-stimulating factor, or G-CSF) and Sandoz is seeking approval for use of its biosimilar in the same indication as the reference medicine.

“Our goal is to improve patient access to important biologic medicines and the EMA file acceptance of our biosimilar pegfilgrastim is a move towards doing just that,” said Mark Levick, MD PhD, Global Head of Development, Biopharmaceuticals.

“At Sandoz, oncology is a key area of focus and, with our biosimilar and generic oncology medicines, we have a leading portfolio in this therapy area. If approved, we look forward to supporting cancer patients, healthcare professionals and payors with our biosimilar pegfilgrastim.”

The comprehensive data package, submitted as part of the Marketing Authorization Application, includes analytical, preclinical and clinical data and strongly demonstrates that the biosimilar pegfilgrastim matches the reference medicine in terms of safety, efficacy and quality.

The clinical development program for Sandoz biosimilar pegfilgrastim includes data from Phase I pharmacokinetic and pharmacodynamic studies in healthy volunteers, as well as Phase III confirmatory safety and efficacy studies in breast cancer patients.

Sandoz is committed to increasing patient access to high-quality biosimilars. As the global leader in biosimilars, Sandoz has five biosimilars marketed worldwide, as well as a leading global pipeline. We currently have three proposed biosimilars under review by the EMA: pegfilgrastim, adalimumab and infliximab.
Sandoz is well-positioned to continue leading the biosimilars industry based on our experience and capabilities in development, manufacturing and commercialization. As a division of Novartis, the first global healthcare company to establish a leading position in both innovative and off-patent medicines, we benefit strongly from this unique blend of experience and expertise in many different market environments.

Disclaimer
This press release contains forward-looking statements within the meaning of the United States Private Securities Litigation Reform Act of 1995. Forward-looking statements can generally be identified by words such as “potential,” “can,” “will,” “plan,” “expect,” “anticipate,” “look forward,” “believe,” “committed,” “investigational,” “pipeline,” “launch,” or similar terms, or by express or implied discussions regarding potential marketing approvals, new indications or labeling for the investigational or approved generic or biosimilar products described in this press release, or regarding potential future revenues from such products. You should not place undue reliance on these statements. Such forward-looking statements are based on our current beliefs and expectations 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 the investigational or approved products described in this press release will be submitted or approved for sale or for any additional indications or labeling in any market, or at any particular time. Neither can there be any guarantee that, if approved, such generic or biosimilar products will be approved for all indications included in the reference product’s label. Nor can there be any guarantee that such products will be commercially successful in the future. In particular, our expectations regarding such products could be affected by, among other things, the uncertainties inherent in research and development, including clinical trial results and additional analysis of existing clinical data; regulatory actions or delays or government regulation generally; the particular prescribing preferences of physicians and patients; competition in general, including potential approval of additional generic or biosimilar versions of such products; 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 products; general economic and industry conditions, including the effects of the persistently weak economic and financial environment in many countries; 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.

About Sandoz
Sandoz is a global leader in generic pharmaceuticals and biosimilars. As a division of the Novartis Group, our purpose is to discover new ways to improve and extend people’s lives. We contribute to society’s ability to support growing healthcare needs by pioneering novel approaches to help people around the world access high-quality medicine. Our portfolio of approximately 1000 molecules, covering all major therapeutic areas, accounted for 2016 sales of USD 10.1 billion. In 2016, our products reached well over 500 million patients and we aspire to reach one billion. Sandoz is headquartered in Holzkirchen, in Germany’s Greater Munich area.

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*  Neulasta^® is a trademark of Amgen Inc.