Sandoz Erelzi (etanercept) Receives Positive Reimbursement Recommendation From Common Drug Review For Treatment Of Multiple Inflammatory Diseases

• Positive recommendation is based on the condition that Erelzi be reimbursed in a manner similar to Enbrel for the treatment of Rheumatoid Arthritis, Ankylosing Spondylitis, and Polyarticular Juvenile Idiopathic Arthritis.
• Positive recommendation moves Erelzi closer to federal, provincial and territorial drug plan reimbursement.
• Erelzi strengthens the leadership of Sandoz in biosimilars and Novartis' leading immunology portfolio. Erelzi is the second Sandoz biosimilar available in Canada.

Sandoz, a Novartis division, and the pioneer and global leader in biosimilars, announced recently that The Canadian Drug Expert Committee (CDEC) as part of the Common Drug Review (CDR) process has issued a positive drug reimbursement recommendation for Erelzi (etanercept)¹. Health Canada granted Erelzi a Notice of Compliance in April 2017. In Canada, Erelzi is 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 Erelzi 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 Erelzi, 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 Erelzi, can be performed safely without any loss of efficacy and safety³.

"This positive recommendation of Erelzi is an important milestone to ensure that patients, with some of the most debilitating inflammatory diseases, may soon have broad access to Erelzi 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."

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 levels³.

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, 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.

* Erelzi is a trademark owned or used under license by Sandoz Canada Inc.
* Enbrel is a registered trademark of Amgen in Canada.

References

¹ CADTH Canadian Drug Expert Committee Recommendation, Etanercept, Erelzi– June 21, 2017, Notice of Final Recommendation, https://www.cadth.ca/etanercept-0

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].