Sandoz, a Novartis division, and the pioneer and global leader in biosimilars, announced 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).
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 option.
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 safety.
“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.”
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.
Cdec, drug reimbursement, sandoz's erelzi, multiple inflammatory diseases
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