Ontario Has Added Erelzi (etanercept) To Public Drug Plan For The Treatment Of Multiple Inflammatory Diseases

• Erelzi has been added to public drug plan based on specific criteria in Ontario for the trea ent of moderate to severe rheumatoid arthritis and for reducing signs and symptoms of active ankylosing spondylitis.
• Erelzi also becomes the first biosimilar indicated for polyarticular juvenile idiopathic arthritis1 under this public drug plan.

Ontario is the most recent province to have added Erelzi (etanercept) to its public drug plan for the treatments of multiple inflammatory diseases. The provincial listing, effective on December 21, 2017, follows the conclusion of an agreement between the pan-Canadian Pharmaceutical Alliance (pCPA) and Sandoz Canada, allowing member provincial, territorial and federal drug plans to fund this therapy for patients. Erelzi , by Sandoz, a Novartis company and the pioneer and global leader in biosimilar medicines, was granted Health Canada approval in April 2017 and was launched in Canada in August 2017. Public access to Erelzi is also available in British Columbia and Prince Edward Island.

Erelzi is reimbursed under specific criteria for the treatments of moderately to severely active rheumatoid arthritis (RA) in adults, and for reducing signs and symptoms of active ankylosing spondylitis (AS). In addition, Erelzi will be the only biosimilar to be reimbursed for the treatments 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 Erelzi 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 Erelzi 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. "Erelzi 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."

Erelzi is available in a pre-filled syringe (PFS) and in the SensoReady pre-filled pen (PFP), an ergonomic device for patients with limited dexterity. Erelzi 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 $332M to $1.81B.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.

About Erelzi
Erelzi is the Sandoz biosimilar of the reference medicine Enbrel. Erelzi has been studied in a global development program, which included a comprehensive comparison of Erelzi 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 Erelzi 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 Erelzi and Enbrel.

The totality of evidence demonstrates that Erelzi 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 Erelzi 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

About Sandoz
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.

For more information, visit www.sandoz.ca.

¹ - Sandoz Canada did not seek a marketing authorization for the trea ent of psoriatic arthritis or plaque psoriasis. Furthermore, it is important to note that Erelzi 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