Joint Statement from the Canadian Association of Gastroenterology (CAG) and Crohn’s and Colitis Canada
The statement is based on a review of evidence comparing biosimilars (available in Canada) to originator biologics for the treatment of patients with inflammatory bowel disease. They evaluated efficacy, safety, cost and acceptance by patients. Ultimately, this 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 biologic previously. This is with the understanding that the price differential between the originator biologic and biosimilar is significant.
- Non-medical switch is not recommended for patients stable on biologic treatment.
- Automatic substitution from a biologic to its biosimilar is not recommended.
The paper will be published in the Journal of the Canadian Association of Gastroenterology.
“It is the position of Robbie’s Rainbow that, while there may be benefit to biosimilars:
- The decision to select a therapy option should be between the IBD patient/caregiver and their gastroenterologist through a shared decision-making process
- Robbie’s Rainbow supports the use of cost-effective therapies; however, safety and efficacy must remain a priority
- A biosimilar should not be automatically considered as an appropriate substitute or interchangeable with its reference biologic, given insufficient data to confirm equivalence.
- Patients should not be required to switch their treatment regimen given the lack of information on the effect of switching from a reference biologic to a biosimilar.
- There should be post marketing surveillance and safety reporting for biosimilars to ensure information about effectiveness and side effects is collected in a consistent manner.
- Biosimilars should have unique non-proprietary names to ensure clarity about the product being prescribed and administered. This will also ensure accurate attribution of side effects and effectiveness.”
“Similar to CAG’s and Health Canada’s position statements on SEBs (Health Canada, 2010a, b; Devlin et al., 2013), the OAG therefore recommends following:
1) SEBs should be regarded as stand-alone products and supported by well-designed non-clinical and clinical studies in a population relevant to Canadian patients.
- Robust evidence must demonstrate SEBs to be as safe and effective as innovator products.
- Evidence must be available for every indication in which the SEB’s manufacturer is seeking approval.
- Extrapolation of indications must be scientifically supported.
2) SEBs cannot be regarded as interchangeable or substitutable with innovator biologics.
- Non-medical switching of stable patients to an SEB is not recommended without sufficient evidence of efficacy, safety, lack of immunogenicity, and long-term follow-up outcomes.
- Only the treating physician, in consultation with the patient, should make the decision to switch the patient to an alternative regimen.
- The OAG feels strongly that the availability of several distinct yet similarly proven biologic therapies (innovator and SEBs) will increase patient and provider options and improve patient outcomes.
3) Prescriptions for innovator biologics should not be automatically substituted for less expensive SEBs by prescribing pharmacies.
- The OAG acknowledges that, to date, no SEB has interchangeability status and therefore automatic substitution rules do not apply.
- However, future decisions regarding any form of switching must be discussed and approved by the treating physician and patient.
4) SEBs should be supported by long-term pharmacovigilance data in a fashion similar to innovator biologics.
- A robust tracking system should be used for all biologics, including SEBs, to ensure proper tracking of safety and efficacy profiles.
- The system would require all biologics to be easily distinguishable by distinct names, including unique non-proprietary names.
- Adverse events must be correctly attributed to the responsible biologic therapy and manufacturer.
5) Policies should acknowledge the environmental complexities associated with the introduction of multiple SEBs for one innovator biologic.
- There is high potential for accidental switching between SEBs at the pharmacy level.
- Data are currently lacking for the safety and efficacy of switching between two or more SEBs of the same innovator biologic, as SEBs are only required to demonstrate their similarity to the innovator biologic, not to one another.
Patients with IBD should have access to safe, effective, and affordable drugs. The OAG requests careful consideration of the above recommendations when reimbursement decisions are being made regarding the use of SEBs for IBD in Canada, and in Ontario specifically. The OAG hopes to work with the Ontario Public Drug Program to further improve the understanding of these challenges and their potential impact on future policy making and reimbursement.”
Health Canada (2010a) Guidance for Sponsors: Information and Submission Requirement for Subsequent Entry Biologics (SEBs). Last updated: May 5, 2010. Accessed: July 13, 2016. Available at: http://www.hc-sc.gc.ca/dhp-mps/brgtherap/applic-demande/guides/seb-pbu/seb-pbu_2010-eng.php.
Devlin SM, Bressler B, Bernstein CN, Fedorak RN, Bitton A et al. (2013) Overview of subsequent entry biologics for the management of inflammatory bowel disease and Canadian Association of Gastroenterology position statement on subsequent entry biologics. Can J Gastroenterol 27 (10): 567-571.