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Sandoz advances its biosimilars program with European Medicines Agency (EMA) acceptance of regulatory submission for biosimilar etanercept

  • Sandoz is seeking approval for all indications included in the reference product’s label which includes chronic inflammatory conditions like rheumatoid arthritis and psoriasis.
  • Sandoz believes that the totality of evidence in its submission, including two pivotal clinical studies, will demonstrate that the biosimilar etanercept is highly similar to the reference product.
  • EMA acceptance follows recent FDA regulatory submission acceptance and is the third of ten regulatory filings planned over a three year period (2015-2017).

Holzkirchen, 8 December, 2015 – Sandoz, a Novartis company and the global leader in biosimilars, announced today that the European Medicines Agency (EMA) has accepted their Marketing Authorization Application (MAA) for a biosimilar to Pfizer’s EU-licensed Enbrel® (etanercept) * - a tumor necrosis factor alpha (TNF-α) inhibitor. Sandoz is seeking approval for all indications included in the label of the reference product which is used to treat a range of autoimmune diseases including rheumatoid arthritis and psoriasis - more than 120 million people in the EU are living with rheumatic and musculoskeletal diseases (RMDs)1 and approx 3.7 million Europeans with psoriasis.2

“Today, only 5% of severe psoriasis patients in North America and Europe have access to life-changing biologic treatment options** such as etanercept" said Mark McCamish, M.D., Ph.D., and Head of Global Biopharmaceutical & Oncology Injectables Development at Sandoz. “The acceptance by the EMA of our biosimilar etanercept regulatory submission is a move towards enabling more patients with chronic inflammatory conditions such psoriasis and rheumatoid arthritis to be treated with biologics” McCamish continued.

The regulatory submission to the EMA consists of a comprehensive data package that includes data from analytical, functional, pre-clinical and clinical studies. Sandoz believes that the two pivotal clinical studies; a pharmacokinetic (PK) study in healthy volunteers (HVs) and a confirmatory safety and efficacy study in patients with chronic plaque-type psoriasis (EGALITY), will provide clinical confirmation of similarity to the reference product established in extensive prior analytical comparability studies.

Sandoz has an unwavering commitment to increasing patient access to high-quality, life-enhancing biosimilars. It is the pioneer and global market leader and currently markets three biosimilars. On 3 September, 2015 Sandoz launched the first biosimilar in the United States and recently had its regulatory submissions for biosimilar etanercept and biosimilar pegfilgrastim accepted by the FDA. Sandoz has a leading pipeline with several biosimilars across the various stages of development including five programs in Phase III clinical trials or registration preparation. The company plans to make 10 regulatory filings over a three year period (2015-2017). As part 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 “seeking,” “will,” “step towards,” “believe,” “commitment,” “signaling,” “pipeline,” “plans,” or similar terms, or by express or implied discussions regarding potential marketing approvals for biosimilar etanercept, or regarding potential future revenues from biosimilar etanercept. 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 etanercept will be approved for sale in Europe, or at any particular time. Neither can there be any guarantee that biosimilar etanercept will be submitted or approved for sale in any additional markets, or at any particular time. Nor can there be any guarantee that biosimilar etanercept will be commercially successful in the future. In particular, management’s expectations regarding biosimilar etanercept 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; competition in general, including potential approval of additional versions of biosimilar etanercept; global trends toward health care cost containment, including government, industry and general public pricing pressures; unexpected litigation outcomes, including intellectual property disputes or other legal efforts to prevent or limit Sandoz from selling biosimilar etanercept; the particular prescribing preferences of physicians and patients; unexpected safety issues; unexpected manufacturing or quality issues; general economic and industry conditions, 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, a Novartis company, is a global leader in generic pharmaceuticals and biosimilars, driving sustainable access to high-quality healthcare. Sandoz employs more than 26,000 people worldwide and supplies a broad range of affordable, primarily off-patent products to patients and customers around the globe. The Sandoz portfolio comprises approximately 1,100 molecules, which accounted for 2014 sales of USD 9.6 billion. Sandoz is headquartered in Holzkirchen, in Germany’s Greater Munich area. The company holds leading global positions in biosimilars as well as in generic anti-infectives, ophthalmics and transplantation medicines.

References
1. http://www.eular.org/myUploadData/files/Biosimilars_2015.pdf (Last accessed 19 September)
2. Davison SC, Allen MH, Mallon E et al (2011) Contrasting patterns of streptococcal superantigen-induced T-cell proliferation in guttate versus chronic plaque psoriasis. Br J Dermatol 145:245–251

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Footnotes:
* Enbrel is a registered trademark of Pfizer
**Patient perspectives in the management of psoriasis: Results from the population-based Multinational Assessment of Psoriasis and Psoriatic Arthritis Survey, MG Lebwohl et al., J Am Acad Dermatol, May 2014