FDA accepts Sandoz regulatory submission for a proposed biosimilar etanercept
Oct 02, 2015
Etanercept is an anti-TNF medicine used to treat a range of immunological diseases including rheumatoid arthritis and psoriasis.
Sandoz is seeking approval for all indications included in the reference product’s label.
Sandoz believes that the totality of evidence in its submission, including two pivotal clinical studies, will demonstrate that the proposed biosimilar is essentially the same as the reference product.
Holzkirchen, Oct. 2, 2015 – Sandoz, a Novartis company and the global leader in biosimilars, announced today that the US Food and Drug Administration (FDA) has accepted its Biologics License Application (BLA) under the 351 (k) pathway for its proposed biosimilar to Amgen’s US-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 affecting approx. 1.3 million1 and 7.5 million2people (respectively) in the US.
Mark McCamish, M.D., Ph.D., and Head of Global Biopharmaceutical & Oncology Injectables Development at Sandoz said “anti-TNFs will continue to play a leading role in immunology treatment and the acceptance of our regulatory submission by the FDA today is a significant step towards increasing patient access to these life-changing medicines.” McCamish continued “we believe we are the first company to receive FDA file acceptance of a biosimilar version of etanercept.”This is the second BLA submission by Sandoz using the 351(k) biosimilar pathway. The BLA 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 confirmation of similarity to the reference product established in prior analytical comparability investigations.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. Sandoz recently launched ZarxioTM (filgrastim-sndz) – the first biosimilar in the United States, signaling a shift toward more competition and affordability in the healthcare system. 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 ten regulatory submissions in the next three years. As part of the Novartis Group, Sandoz is uniquely positioned to lead the biosimilars industry based on its experience and capabilities in development, manufacturing and commercialization.
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The foregoing release contains forward-looking statements that can be identified by words such as “proposed,” “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 the United States, 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.
Sandoz, a Novartis company, is a global leader in generic pharmaceuticals, 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 global portfolio comprises approximately 1,100 molecules, which accounted for 2014 sales of USD 9.6 billion. Sandoz holds the global #1 position in biosimilars as well as in generic anti-infectives, ophthalmics and transplantation medicines.Nearly half of Sandoz's portfolio is in differentiated products – products that are scientifically more difficult to develop and manufacture than standard generics. In addition to strong organic growth since consolidating its generics businesses under the Sandoz brand name in 2003, Sandoz has consistently driven growth in selected geographies and differentiated product areas through a series of targeted acquisitions.