ErelziTM is reimbursed under specific criteria for the treatment of moderately to severely active rheumatoid arthritis (RA) in adults, and for reducing signs and symptoms of active ankylosing spondylitis (AS). In addition, ErelziTM will be the only biosimilar to be reimbursed for the treatment of polyarticular juvenile idiopathic arthritis (JIA) in patients aged 4 to 17.1 JIA is a condition that affects about three out of 1,000 children and teenagers in Canada.2
"The biosimilar ErelziTM adds to the choices that patients and rheumatologists have to treat inflammatory arthritis such as rheumatoid arthritis, ankylosing spondylitis and juvenile arthritis," said Dr. Janet Pope, Professor of Medicine in the Division of Rheumatology, Epidemiology, and Biostatistics at the University of Western Ontario, Schulich School of Medicine, London. "The government of Ontario is demonstrating its commitment to making therapy for these diseases more broadly available in order to improve the lives of more patients."
"Sandoz is pleased that Ontario recognizes the important impact that access to ErelziTM can have on reducing the burden of disease and delivering important savings to the healthcare system and the public drug plan," said Nadia Turchetta, Executive Director, Biopharmaceuticals, Sandoz Canada. "ErelziTM is another concrete example of how Sandoz is making access happen by offering high-quality medicines at a more affordable price, which will deliver important savings to the healthcare system."
ErelziTM is available in a pre-filled syringe (PFS) and in the SensoReady® pre-filled pen (PFP), an ergonomic device for patients with limited dexterity. ErelziTM is available in a 25 mg and 50 mg PFS, and is the only etanercept available in a 25 mg PFS.
A biosimilar is a biologic that is launched after the loss of patent exclusivity on the reference biologic. It matches its reference biologic in terms of safety, efficacy and quality, having demonstrated therapeutic equivalence to a biologic reference medicine. Biosimilars have the potential to increase access to effective treatments for patients, as well as reduce the ongoing economic burden currently existing in the Canadian healthcare system that is impacting patients, physicians and payers. Recently, Canada's Patented Medicine Prices Review Board estimated that the potential cost savings from biosimilars could range from $332 million to $1.81 billion.3
Sandoz is committed to increasing patient access to high-quality, life-enhancing biosimilars. Sandoz markets five biosimilars in Europe. As a division of Novartis, the first global healthcare company to establish a leading position in both innovative and off-patent medicines, Sandoz benefits strongly from this unique blend of experience and expertise in many different market environments.
ErelziTM is the Sandoz biosimilar of the reference medicine Enbrel®. ErelziTM has been studied in a global development program, which included a comprehensive comparison of ErelziTM and Enbrel® at the analytical, preclinical, and clinical levels. The program included preclinical studies, pharmacokinetic (PK) studies, and the Phase III confirmatory safety and efficacy EGALITY study between Erelzi™ and Enbrel®.
Health Canada approval was based on a comprehensive development program consisting of comparative analytical, preclinical, and clinical data demonstrating biosimilarity to the reference medicine, Enbrel®.
Studies included: analytical (extensive comparative physicochemical and functional assessment of ErelziTM and the reference biologic drug), preclinical, Phase I pharmacokinetic (PK), and the Phase III confirmatory study EGALITY– an innovative safety and efficacy study in a sensitive indication to detect potential differences between ErelziTM and Enbrel®.
The totality of evidence demonstrates that ErelziTM is highly similar to Enbrel® in terms of structure, function, PK, efficacy, safety and immunogenicity. Based on this evidence, Health Canada granted market authorization to ErelziTM indicated for: treatment of moderately to severely active rheumatoid arthritis (RA) in adults, reducing signs and symptoms of moderately to severely active polyarticular juvenile idiopathic arthritis (JIA) in patients aged 4 to 17 years and reducing signs and symptoms of active ankylosing spondylitis (AS).1
The foregoing release contains forward-looking statements that can be identified by words such as "potential," "can," "soon," "committed," or similar terms, or by express or implied discussions regarding potential additional marketing approvals or labeling for ErelziTM, or any of the other potential products in the Sandoz biosimilar pipeline, or regarding potential future revenues from ErelziTM, the other marketed products in the Sandoz biosimilar portfolio, and the potential products in the Sandoz biosimilar pipeline. 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 ErelziTM or any of the other marketed products in the Sandoz biosimilar portfolio will be submitted or approved for sale in any additional markets, or at any particular time. Neither can there be any guarantee that any of the potential products in the Sandoz biosimilar pipeline will be submitted or approved for sale in any market, or at any particular time. Nor can there be any guarantee that ErelziTM if approved, any of the potential products in the Sandoz biosimilar pipeline will be approved for any or all of the indications in the respective reference product's label. Nor can there be any guarantee that ErelziTM, the other marketed products in the Sandoz biosimilar portfolio, or the potential products in the Sandoz biosimilar pipeline will be commercially successful in the future. In particular, management's expectations regarding ErelziTM and such other biosimilar candidates and marketed products 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 ErelziTM; global trends toward health care cost containment, including government, payer 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 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.
Sandoz Canada is part of Sandoz International GmbH and a subsidiary of Swiss multinational Novartis AG. A leader in its field, Sandoz Canada develops, markets and distributes a broad line of generic, biosimilar, consumer and specialty products.
Sandoz, a division of the Novartis Group, is a global leader in generic pharmaceuticals and biosimilars. Our mission 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 global portfolio of approximately 1000 molecules, covering all major therapeutic areas, accounted for 2016 sales of USD 10.1 billion. In 2016, our global portfolio of 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.
TM: Erelzi is a trademark owned or used under license by Sandoz Canada Inc.®: Enbrel is a trademark owned by Amgen.
1 - Sandoz Canada did not seek a marketing authorization for the treatment of psoriatic arthritis or plaque psoriasis. Furthermore, it is important to note that ErelziTM products are not suitable for patients who weigh 63 kg or under according to the Ontario Rheumatology Association.
2 - The Arthritis Society: https://www.arthritis.ca/about-arthritis/types-of-arthritis-(a-z)/types/childhood-arthritis, accessed on November 15, 2017
3 - Potential savings for Biosimilars in Canada : Government of Canada: http://www.pmprb-cepmb.gc.ca/view.asp?ccid=1304: accessed on November 15, 2017
For interview opportunities, please contact Annick Lambert (see contact information below).
SOURCE Sandoz Canada
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