The Canadian Association of Gastroenterology (CAG) and Crohn’s and Colitis Canada announced on 24 October 2019 that they had issued a joint position statement on the use of biosimilars for the treatment of inflammatory bowel disease (IBD) [1].
Crohn’s and Colitis Canada is a national, volunteer-based charity focused on finding cures for Crohn’s disease and ulcerative colitis.
The CAG’s members include gastroenterologists, surgeons, paediatricians, basic scientists and nurses. The association provides professional gastroenterological education and funding opportunities for gastrointestinal health and disease research, and more recently, has advocated for improved timeliness and quality of digestive health care for Canadians.
Using the GRADE approach*, authors reviewed evidence comparing biosimilars (available in Canada) to originator biologicals for the treatment of patients with IBD. They evaluated efficacy, safety, cost and acceptance by patients.
The joint paper made the following recommendations:
• Patients may be started on a biosimilar if they have active disease and have not been exposed to that biological previously. This is with the understanding that the price differential between the originator biological and biosimilar is significant.
• Non-medical switching is not recommended for patients stable on biological treatment.
• Automatic substitution from an originator biological to its biosimilar is not recommended.
Dr Paul Moayyedi, Audrey Campbell Chair of Ulcerative Colitis Research at McMaster University said that ‘there are a number of position statements from various organizations but none of these provide an explicit literature search or assessment of the quality of evidence of a defined clinical question according to GRADE criteria’. He added that the association ‘felt that this was critical in demonstrating the evidence base for our joint position’.
Crohn’s and Colitis Canada updated its position statement on the use of biosimilars for IBD in September 2019 [2]. In their statement they also asserted that ‘non-medical switching from an originator biological to its biosimilar is not in the best interest of patients’.
Canada has one of the highest rates of Crohn’s and colitis in the world. Today, more than 270,000 Canadians have Crohn’s and colitis, a number that is expected to increase to over 400,000 within the next decade.
European IBD specialists have come out in support of switching to biosimilars following appropriate discussion between physicians, nurses, pharmacists and patients, and according to national recommendation [3]. The European Crohn’s and Colitis Organization (ECCO) based its recommendation on the current regulatory guidance from the European Medicines Agency and the evidence about efficacy and safety of biosimilars in IBD patients.
The GRADE system entails an assessment of the quality of a body of evidence for five factors:
• Within-study risk of bias (methodological quality)
• Directness of evidence
• Heterogeneity (any kind of variability among studies)
• Precision of effect estimates
• Risk of publication bias
Randomized trials; or double-upgraded observational studies are rated as high quality, downgraded randomized trials; or upgraded observational studies are rated as moderate, double-downgraded randomized trials; or observational studies are rated as low quality and triple-downgraded randomized trials; or downgraded observational studies; or case series/case reports are rated as being of very low quality.
*GRADE defines the quality of a body of evidence as the extent to which one can be confident that an estimate of effect or association is close to the quantity of specific interest.
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References
1. Moayyedi P, Benchimol EI, Armstrong D, et al. Joint Canadian Association of Gastroenterology and Crohn’s Colitis Canada Position Statement on biosimilars for the treatment of inflammatory bowel disease. J Can Assoc Gastroenterol. 2019;XX(XX):1-9.
2. GaBI Online - Generics and Biosimilars Initiative. Canadian IBD charity updates biosimilar position statement [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2019 Dec 13]. Available from: www.gabionline.net/Biosimilars/General/Canadian-IBD-charity-updates-biosimilar-position-statement
3. GaBI Online - Generics and Biosimilars Initiative. European IBD specialists support switching to biosimilars [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2019 Dec 13]. Available from: www.gabionline.net/Biosimilars/General/European-IBD-specialists-support-switching-to-biosimilars
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