Quebec Adds Erelzi (Etanercept) To Provincial Drug Plans For The Treatment Of Multiple Inflammatory Diseases

• Erelzi has been added to the Quebec Drug Insurance Plan based on specific criteria for the treatment 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 in Quebec.

Quebec is the most recent province to have added Erelzi (etanercept) 50 mg to its formulary of exception drugs covered by the province's Public Prescription Drug Insurance Plan for the treatment of multiple inflammatory diseases. The provincial listing has been in effect since February 1, 2018. Sandoz, a Novartis division and the pioneer and global leader in biosimilar medicines, was granted Health Canada approval for Erelzi in April 2017 and Sandoz Canada launched the biosimilar in Canada in August 2017.

"The biosimilar Erelzi adds to the options that patients and rheumatologists have to treat inflammatory arthritis such as rheumatoid arthritis, ankylosing spondylitis and juvenile arthritis," said Dr. Denis Choquette, Professor of Medicine at the University of Montreal, Quebec, and co-founder of the Institute of Rheumatology of Montreal. "Quebec is demonstrating its commitment to making therapy for these diseases more affordable and broadly available to improve the lives of more patients."

"Sandoz is pleased that Quebec recognizes the important impact 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 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). Additionally, Erelzi 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 in every 1,000 children and teenagers across Canada.²

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.

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. Biosimilar medicines 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 currently markets five biosimilars in Europe, more than any other company. 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.

The totality of evidence demonstrates that Erelzi matches 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 Canada
Sandoz Canada is part of Sandoz International GmbH, a global leader in generic pharmaceuticals and biosimilars 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. For more information, visit www.sandoz.ca.

About Sandoz International GmbH
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 approximately 1000 molecules, covering all major therapeutic areas, accounted for 2017 sales of USD 10.1 billion. In 2017, 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.

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 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