Second etanercept biosimilar approved in Canada

Generics and biosimilars Initiative

Building trust in cost-effective treatments

Sign up
eng / esp

Second etanercept biosimilar approved in Canada

Biosimilars/News | Posted 22/09/2017 0 Post your comment

Sandoz, the generics division of Novartis, announced on 21 August 2017 that its etanercept biosimilar, Erelzi, is now available in Canada.

Etanercept is a biological drug that treats autoimmune diseases by inhibiting tumour necrosis factor (TNF); a soluble inflammatory cytokine. Etanercept is indicated for the treatment of rheumatoid, juvenile rheumatoid and psoriatic arthritis, plaque psoriasis and ankylosing spondylitis.

The news follows the positive drug reimbursement recommendation for Erelzi from the Canadian Drug Expert Committee (CDEC) as part of the Common Drug Review (CDR). Health Canada granted Erelzi a Notice of Compliance in April 2017.

Erelzi is a biosimilar of Amgen/Pfizer’s Enbrel (etanercept). The biosimilar application for Erelzi included data from Sandoz’s EGALITY study [1], which ‘has shown that Erelzi is safe and effective, and switching patients from Enbrel to Erelzi can be performed safely without any loss of efficacy’, according to 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, Ontario, Canada.

Erelzi has been approved in Canada for the treatment of ankylosing spondylitis and moderately to severely active rheumatoid arthritis in adults, as well as polyarticular juvenile idiopathic arthritis in patients aged 4 years or older.

Erelzi is the second etanercept biosimilar to be approved by Health Canada. Merck Canada’s Brenzys (etanercept) was the first etanercept biosimilar to be approved by the agency back in August 2016 [2]. Brenzys, however, is only approved for ankylosing spondylitis and rheumatoid arthritis, and not for juvenile idiopathic arthritis. Sandoz states that Erelzi is the ‘first biosimilar approved to treat juvenile idiopathic arthritis’.

Sandoz also has a somatropin biosimilar approved in Canada. Omnitrope (somatropin) was approved for the treatment of growth hormone deficiency in adults and children in April 2009 [2].

Erelzi was also approved in Europe in June 2017 [3].

Related article
Biosimilars of etanercept

References
1. GaBI Online - Generics and Biosimilars Initiative. Positive results for etanercept and bevacizumab biosimilars [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2017 Sep 22]. Available from: www.gabionline.net/Biosimilars/Research/Positive-results-for-etanercept-and-bevacizumab-biosimilars
2. GaBI Online - Generics and Biosimilars Initiative. Subsequent entry biologics approved in Canada [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2017 Sep 22]. Available from: www.gabionline.net/Biosimilars/General/Subsequent-entry-biologics-approved-in-Canada
3. GaBI Online - Generics and Biosimilars Initiative. Biosimilars approved in Europe [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2017 Sep 22]. Available from: www.gabionline.net/Biosimilars/General/Biosimilars-approved-in-Europe

Permission granted to reproduce for personal and non-commercial use only. All other reproduction, copy or reprinting of all or part of any ‘Content’ found on this website is strictly prohibited without the prior consent of the publisher. Contact the publisher to obtain permission before redistributing.

Source: Health Canada, Sandoz