Sandoz Proposed Biosimilars Adalimumab And Infliximab Accepted For Regulatory Review By The EMA

• Sandoz is seeking approval for their proposed biosimilars adalimumab and infliximab for use in all indications of their respective reference medicines, Humira®* and Remicade®**
• Comprehensive data packages demonstrate each biosimilar matches its respective reference medicine in terms of quality, efficacy and safety
• These regulatory submissions follow soon after two positive CHMP opinions*** for Sandoz biosimilars etanercept and rituximab further reinforcing Sandoz immunology pipeline and the broader Novartis immunology portfolio

Holzkirchen, 31 May, 2017 - Sandoz, a Novartis division, and the pioneer and global leader in biosimilar medicines announced today that the European Medicines Agency (EMA) has accepted for regulatory review their Marketing Authorization Applications for biosimilars to AbbVie’s Humira^® (adalimumab) and Janssen’s Remicade^® (infliximab) both of which are used to treat immunological diseases. Sandoz is seeking approval for biosimilar adalimumab and infliximab for use in all indications of their respective reference medicines.

“Patients with autoimmune diseases such as rheumatoid arthritis and inflammatory bowel disease rely on biologic medicines like adalimumab and infliximab to stay well, but unfortunately access to these essential medicines can be limited” said Mark Levick MD PhD, Global Head of Development, Biopharmaceuticals, Sandoz. “The EMA’s acceptance of our regulatory submissions for our biosimilar adalimumab and infliximab is a significant step towards improving patient access to these important biologic medicines, both of which are part of our steadily advancing immunology pipeline”.

The comprehensive data packages included in the EMA submissions demonstrate biosimilarity of the proposed biosimilars to their respective reference medicines, with analytical, preclinical and clinical data matching across quality, efficacy and safety.

• The biosimilar adalimumab submission included clinical data from pharmacokinetic (PK) studies and a Phase III confirmatory efficacy and safety study in patients with moderate to severe chronic plaque psoriasis[1].
• The biosimilar infliximab submission included clinical data from a PK study and a Phase III confirmatory efficacy and safety, study in rheumatoid arthritis[2].

Sandoz is committed to increasing patient access to high-quality, life-enhancing biosimilars. It is the pioneer and global leader in biosimilars, and currently markets three biosimilars worldwide. Sandoz has a leading biosimilar pipeline and following positive CHMP opinions for biosimilars rituximab and etanercept (April 2017), it is on track to launch five biosimilars of major oncology and immunology biologics, including adalimumab and infliximab, by 2020. As a division of the Novartis Group, Sandoz is well-positioned to lead the biosimilars industry based on its experience and capabilities in development, manufacturing and commercialization.

Disclaimer
The foregoing release contains forward-looking statements that can be identified by words such as “proposed,” “seeking approval,” “positive CHMP opinions,” “pipeline,” “step towards,” “advancing,” “committed,” “on track,” “launch,” “well-positioned,” “recommended,” or similar terms, or by express or implied discussions regarding potential marketing approvals or labeling for biosimilar adalimumab, biosimilar infliximab, biosimilar rituximab, biosimilar etanercept, or any of the other products in the Sandoz biosimilar pipeline, or regarding potential future revenues from biosimilar adalimumab, biosimilar infliximab, biosimilar rituximab, biosimilar etanercept, the other products in the Sandoz biosimilar pipeline and the broader Novartis immunology portfolio. 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 adalimumab, biosimilar infliximab, biosimilar rituximab, biosimilar etanercept, or any of the other products in the Sandoz biosimilar pipeline will be submitted or approved for sale in any market, or at any particular time. Neither can there be any guarantee that, if approved, biosimilar adalimumab, biosimilar infliximab, biosimilar rituximab or biosimilar etanercept will be approved for all indications included in the reference products’ respective labels. Nor can there be any guarantee that biosimilar adalimumab, biosimilar infliximab, biosimilar rituximab, biosimilar etanercept, or any of the other products in the Sandoz biosimilar pipeline or the broader Novartis immunology portfolio will be commercially successful in the future. In particular, management’s expectations regarding biosimilar adalimumab, biosimilar infliximab, biosimilar rituximab, biosimilar etanercept, and other products in the Sandoz biosimilar pipeline and the broader Novartis immunology portfolio 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 adalimumab, biosimilar infliximab, biosimilar rituximab or biosimilar etanercept; 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 biosimilar adalimumab, biosimilar infliximab, biosimilar rituximab, biosimilar etanercept, or its other 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.

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.

* Humira^® is a registered trademark of AbbVie Biotechnology Ltd.
** Remicade^® is marketed by MSD in Europe and is a registered trademark of Janssen Biotech, Inc.
*** Sandoz press release https://www.sandoz.com/news/media-releases/sandoz-proposed-biosimilars-rituximab-and-etanercept-recommended-approval-europe (last accessed 28 April 2017)

Sandoz acquired the rights from Pfizer for the development, commercialization and manufacture of PF-06438179 in the 31 countries that form the European Economic Area (EEA) in February 2016 where it is known as GP1111. Pfizer retains commercialization and manufacturing rights to infliximab in all countries outside of the EEA.

References

1. Blauvelt A et al. A randomized, double-blind, multicenter study to compare
   the efficacy, safety, and immunogenicity of a proposed adalimumab biosimilar (GP2017) with originator adalimumab Poster #5224 presented at the 2017 American Academy of Dermatology (AAD) Annual Meeting, 3-7 March 2017.
2. Pfizer Inc. Pfizer Announces Positive Top-Line Results from REFLECTIONS B537-02 Study for PF-06438179 (infliximab-Pfizer) a Potential Biosimilar to Remicade^® (infliximab). Available at:http://www.pfizer.com/news/press-release/press-release-detail/pfizer_announces_positive_top_line_results_from_reflections_b537_02_study_for_pf_06438179_infliximab_pfizer_a_potential_biosimilar_to_remicade_infliximab (last accessed 05 May 2017).

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