DSEN Abstract
Comparative Effectiveness and Safety of Biosimilars Versus Originator Biologics
Summary
Biologics are an effective treatment option for many people with immune-mediated inflammatory conditions, but they are expensive – some cost ~$30,000 yearly per individual. Biosimilars are highly similar versions of the originator biologic, potentially reducing healthcare costs. To support evidence-based decision-making, we established the CAN-AIM Biosimilars Registry to compare safety and effectiveness of biosimilar versus originator biologics. In our analyses, we found no meaningful differences, comparing biosimilar versus originator, in treatment persistence, time to clinical remission, disease activity, changes in quality of life or risk of serious adverse events. These findings provide much-needed reassurance to regulators, clinicians, and the patients who are looking for safe, effective treatment.
Key message
The CAN-AIM Biosimilar Registry provides robust, real-world evidence showing no meaningful difference in effectiveness and safety between biosimilar with originator biologics.
Authors: Sasha Bernatsky, Cristiano S. Moura, Autumn Neville and the CAN-AIM investigative team
For more information, please contact:
sasha.bernatsky@mcgill.ca
What is the issue?
Biologics have transformed the treatment of many diseases but their high-cost place a significant burden on healthcare systems. The introduction of more affordable biosimilars led provinces to implement non-medical switching policies that required patients on originator biologics to transition to biosimilars. In 2017, Health Canada highlighted the need for real-world evidence on the clinical impact of transitioning to biosimilars, including maintenance of disease control and long-term treatment effectiveness.
What was the aim of the study?
To compare outcomes among individual initiating or switching to biosimilar versus originator biologics, including:
- Treatment discontinuation/persistence, clinical remission, and serious adverse events
- Changes in disease activity
- Health-related quality of life
How was the study conducted?
Established the CAN-AIM Biosimilar Registry, which includes data on over 1,700 treatment episodes involving biosimilars and originator biologics. Data were obtained from:
- Canadian prospective clinical cohorts of immune-mediated inflammatory conditions –inflammatory arthritis (IA) disease (rheumatoid arthritis and ankylosing spondylitis) and inflammatory bowel diseases (IBD, ulcerative colitis and Crohn’s disease)
- Administrative data: National Prescription Drug Utilization Information System (NPDUIS, Canada); United States commercial insurance data (MarketScan)
What did the study find?
- Treatment persistence and discontinuation were similar between biosimilar and originator biologics users across all biologics and disease groups studied.
- No meaningful differences in discontinuation rates for infliximab/etanercept biosimilars vs. originators in IA patients; comparable persistence among adalimumab/infliximab biosimilars vs. originator in IBD patients
- Remission outcomes, including time to first remission and sustained remission, were similar in patients initiating biosimilars vs. originator biologics
- No increased risk of serious adverse outcomes (serious infections, hospitalizations, or malignancy) for biosimilars versus originators:
- NPDUIS: no differences in serious infections or cancer risk in rheumatoid arthritis patients on etanercept/infliximab biosimilars vs. originators
- MarketScan: No significant difference in infection risk for infliximab users
- IBD cohort data: hospitalization/emergency visit rates were comparable between biosimilar and originator infliximab users.
- Improvements in health-related quality of life, measured using the Short Inflammatory Bowel Disease Questionnaire, were observed in both biosimilar and originator (infliximab) users, with no meaningful differences between groups.
Link to manuscripts.
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