|1. Why did the CRA issue a new position statement?
Evidence for the benefits and risks of using biosimilars in the management of rheumatic diseases has accrued rapidly since their introduction. This updated position statement represents the status of evidence-based medicine based on the latest findings to ensure that Association members, and their patients, are in possession of up-to-date guidance regarding the use of such products so that informed and appropriate treatment decisions may be made.
2 What is the CRA’s position regarding the use of biosimilars?
The CRA’s position statement on biosimilars is available in full on our website.
• Rheumatologists should continue to provide the best care possible for individual patients while also being fiscally responsible for the benefit of society as a whole. As such, they should consider choosing the most cost-effective product when there is a choice available between a reference biologic and a biosimilar.
• It is imperative that a decision to prescribe a biosimilar, or a decision to substitute or transition/change treatment to a biosimilar, follows a respectful and informed discussion between the patient and their rheumatologist; does not result in any interruption in patient care and does not result in additional cost to the patient.
• The Canadian Rheumatology Association continues to monitor the data available regarding the safety and efficacy of biosimilars in the management of rheumatic diseases and will provide further updates to this position statement as needed.
3. How does this position statement differ from the previous version?
The previous position statement, released in May 2017, reflected the evidence available at that time. This new position statement, developed by a core group including various internal committees and advisors and reviewed and approved by the CRA board of directors, represents the evolution in our understanding of the benefits and risks of biologics as new data has accrued.
4. What is the rationale for the change?
Data from numerous clinical trials in addition to global post-marketing surveillance have tempered many of the early concerns related to the substitution/transition/change of biosimilars for reference biologics. This is reflected in the updated position statement released by the CRA.
5. Who was involved in the development of the position statement?
The position statement was developed by a core group including various internal committees and advisors and reviewed and approved by the CRA board of directors. The position statement was developed and then circulated to the members of the therapeutics committee to provide input. The statement was modified according to this feedback and finally approved by the therapeutics committee before submission to the Board. This position statement was developed independently by the CRA for physicians so they can offer up-to-date guidance regarding the use – and potential benefits and risks – of all treatment options so informed and appropriate treatment decisions may be made.
6. Is there any ongoing research in Canada looking at the use of biosimilars in people living with rheumatic diseases?
There is one trial currently being conducted in Canada that is listed on clinicaltrials.gov, involving the use of biosimilars in patients naïve to or previously using a reference biologic. However, numerous trials have been undertaken elsewhere evaluating the safety and efficacy of biosimilars and this accrual of data is the main reason for the update to this position statement.
7. What is the difference between a guideline, a consensus statement and a position statement?
The CRA classifies its guidance into clinical practice guidelines and position statements. Clinical practice guidelines follow international standards for best practice and provide recommendations for best practice based on the latest evidence. A Position Statement is a document that outlines CRA’s stance on a topic relevant to its membership. They are generally developed as a quick response to emerging or controversial issues. Although there is usually insufficient time to adopt the same rigorous approach as Clinical Practice Guidelines, position statements still refer to appropriate evidence-based literature and must be approved by the CRA prior to being released.
8. Will this position statement be included in new CRA guidelines when they are developed?
As our guidelines are updated, new information will always be considered as part of the review process.
9. How often will you update this position statement?
The position statement will be updated when new information or clinical evidence becomes available.