·Positive recommendation is based on the condition that ErelziTM be reimbursed in a manner similar to Enbrel® for the treatment of Rheumatoid Arthritis, Ankylosing Spondylitis, and Polyarticular Juvenile Idiopathic Arthritis.
·Positive recommendation moves ErelziTM closer to federal, provincial and territorial drug plan reimbursement.
·ErelziTM strengthens the leadership of Sandoz in biosimilars and Novartis’ leading immunology portfolio.ErelziTM is the second Sandoz biosimilar available in Canada.
Boucherville, (August 2, 2017) – Sandoz, a Novartis division, and the pioneer and global leader in biosimilars, announced today that The Canadian Drug Expert Committee (CDEC) as part of the Common Drug Review (CDR) process has issued a positive drug reimbursement recommendation for ErelziTM (etanercept)1. Health Canada granted ErelziTM a Notice of Compliance in April 2017. In Canada, ErelziTMis approved for the treatment of Ankylosing Spondylitis (AS), and for the treatment of moderately to severely active Rheumatoid Arthritis (RA) in adults, and Polyarticular Juvenile Idiopathic Arthritis (JIA) in patients aged 4 years or older. This positive recommendation is based on ErelziTM being reimbursed in a manner similar to Enbrel® and for use in patients for whom etanercept is considered to be the most appropriate treatment option2.
In addition to the potential significant cost savings provided by ErelziTM, the recommendation also recognizes the clinical value of the therapy based on results from the Phase 3 EGALITY study that demonstrated switching patients from Enbrel® to ErelziTM,can be performed safely without any loss of efficacy and safety3.
“This positive recommendation of ErelziTM is an important milestone to ensure that patients, with some of the most debilitating inflammatory diseases, may soon have broad access to ErelziTM under public drug plans in Canada,” said Michel Robidoux, President and General Manager of Sandoz Canada. “Unfortunately, as it stands today, not all Canadians living with arthritis have the same access to biologics. Sandoz is committed to increasing patient access to high-quality, life-enhancing biologics while working with the provincial and territorial public drug plans to reduce financial pressures on our healthcare systems.”
ErelziTMis theSandoz 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 levels3.
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. Neither 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, 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 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, manufactures, markets and distributes a broad line of generic, biosimilar, consumer and specialty products.
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 global 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.
* ErelziTMis a trademark owned or used under license by Sandoz Canada Inc.
* Enbrel® is a registered trademark of Amgen in Canada.
2.Sandoz Canada has not sought the approval of ErelziTM for the treatment of psoriatic arthritis or plaque psoriasis at this time.
3.Griffiths C, et al. The EGALITY study: a confirmatory, randomized, double-blind study comparing the efficacy, safety and immunogenicity of GP2015, a proposed etanercept biosimilar, vs. the originator product in patients with moderate-to-severe chronic plaque-type psoriasis. Br J Dermatol 2017; 176: 928-938. Available from: DOI 10.1111/bjd.15152 [Accessed: June 2017].