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 was 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
To compare, in biologic-naive patients who are new users of biosimilar drugs versus their equivalent legacy drugs:
- Frequency of discontinuation of the initial therapy
- Persistence on the initial therapy (time until drug discontinuation)
- Frequency of patients starting or increasing prednisone or other immunosuppressive drugs
- Frequency of and time to discontinuation of treatment due to ineffectiveness
- Frequency of and time to clinical remission/induction of response
- Frequency of and time to serious adverse events
To describe in biologic-naïve patients who are new users of biosimilar drugs or their equivalent legacy drugs:
- Change in disease activity over time
- The frequency of, and time to, long-term outcomes (sustained remission, erosions in RA, radiographic progression in AS, and endoscopic mucosal healing scores in CD and UC).
- Change in quality of life measures over time
1.To describe the above outcomes in patients switching from the legacy drug, to the biosimilar.
2. To describe the above outcomes in patients switching from the biosimilar to the legacy drug.
For more details, we invite you to read our protocol: CAN-AIM Biosimilar Protocol