Q# 17-05: Comparative Effectiveness and Safety of Biosimilars and Legacy Drugs
In Canada, and worldwide, there is a need for updated, independent, real-world comparative effectiveness and safety data related to biologic drugs including biosimilar drugs.
CAN-AIM has recently been awarded DSEN funds to study this important issue. The request for these data came from the Pharmaceutical Policy Division in the Office of Pharmaceutical Management at Health Canada’s Strategic Policy Branch
The primary aim is to compare, in biologic-naive patients initiating biosimilar drugs versus their originator drugs:
1. Frequency of discontinuation of the initial therapy
2. Persistence on the initial therapy (time until drug discontinuation)
3. Frequency of initiating/increasing steroids or DMARDs
4. Frequency of and time to treatment d/c due to ineffectiveness
5. Frequency of and time to clinical remission/induction of response
6. Frequency of and time to serious adverse events
The secondary aim is to describe which biologic-naive patients initiate biosimilar drugs vs. their bio-originator:
1.Change in disease activity over time
2.Frequency of, time to, long term outcomes (sustained remission, damage)
3.Change in quality of life measures over time
4.Average change in steroid dose from baseline to one year.
5.Ability to decrease or discontinue prednisone
Exploratory aim – To describe the outcomes above in:
1.those switching from bio-originator, to biosimilar.
2.those switching from biosimilar to bio-originator
For more details, we invite you to read our protocol: CAN-AIM Biosimilar Protocol