SOURCE: Sandoz


June 28, 2016 09:00 ET

Sandoz Canada Regulatory Submission for Subsequent Entry Biologic Etanercept Accepted for Review by Health Canada

BOUCHERVILLE, QC--(Marketwired - June 28, 2016) - Sandoz Canada announced today that Health Canada has accepted for review its regulatory submission for a subsequent entry biologic version (also known as biosimilar) of etanercept, a tumor necrosis factor alpha (TNF-alpha) inhibitor. Subsequent entry biologics are follow-on versions of original biological molecules and undergo their own confirmatory clinical safety and efficacy studies as the final part of a comprehensive comparability exercise.

Sandoz biosimilar etanercept was accepted by the FDA and EMA for regulatory review in the last quarter of 2015.

"With 250 million patient days of experience across the globe since being on the market, Sandoz is committed to increasing patient access to high-quality, life-enhancing biosimilars. These medicines generate significant savings to the Canadian healthcare system," said Michel Robidoux, President and General Manager of Sandoz Canada.

A recent report published by IMS notes that the surge in biosimilar medicines will drive significant change in health system costs, patient access and competition by 2020, and that patient access to biologic treatments has grown by as much as 100 percent following the availability of biosimilars ("Delivering on the Potential of Biosimilar Medicines, The Role of Functioning Competitive Markets" report, IMS Institute for Healthcare Informatics, March 2016).

Last year, Sandoz Canada received approval from Health Canada for a number of additional indications for PrOmnitrope®, a recombinant human growth hormone used to treat growth problems in both pediatric and adult patients. PrOmnitrope® was Canada's first biosimilar.

Sandoz is the pioneer and global leader in biosimilars and announced last week its plans to launch five biosimilars of major oncology and immunology biologics across key geographies by 2020, aiming at broadening access to these treatments for more patients. The five launches will be enabled by an aggressive regulatory submissions strategy of 11 filings over a three-year period (2015-2017).

Furthermore, plans to invest over USD 1 billion, between 2010 and 2020, in state-of-the-art biomanufacturing facilities in Schaftenau and Kundl, Austria, are expected to ensure that Sandoz' biosimilar medicines reach patients and healthcare professionals around the world. 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.

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The foregoing release contains forward-looking statements that can be identified by words such as "proposed," "commitment," "seeking," "believes," "will," "planned," "potentially," "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 Canada, 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 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 over 1000 molecules, covering all major therapeutic areas, accounted for 2015 sales of USD 10.1 billion. In 2015, our products reached more than 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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