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In Vitro Methods for Comparing Target Binding and CDC Induction Between Therapeutic Antibodies: Applications in Biosimilarity Analysis
Published on: May 4, 2017
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Switching Between Epoetins: A Practice in Support of Biosimilar Use
Carmen D'Amore1, Roberto Da Cas1, Mariangela Rossi2
1Pharmacoepidemiology Unit, National Centre for Epidemiology, National Institute of Health, Viale Regina Elena 299, 00161, Rome, Italy.
Summary
Switching between different erythropoiesis-stimulating agents (ESAs) is common, occurring in 12.2% of patients and influenced by treatment duration. This practice is not limited to biosimilars, offering reassurance for ESA transitions.
Area of Science:
- Pharmacoeconomics and Drug Utilization Research
- Clinical Pharmacology
- Health Services Research
Background:
- Concerns exist regarding the acceptability of switching between reference biological drugs and their biosimilars.
- It remains unclear if these concerns are exclusive to biosimilars or apply to switching between any biological agents.
Purpose of the Study:
- To quantify the frequency of switching among different erythropoiesis-stimulating agents (ESAs).
- To investigate factors influencing ESA switching behavior in a real-world setting.
Main Methods:
- Retrospective drug utilization study in the Umbria region, Italy.
- Analysis of epoetin prescriptions from July 2011 to December 2014.
- Survival analysis to model switching probability based on treatment duration.
Main Results:
- 354 out of 2896 patients (12.2%) switched epoetins.
- Switching probability increased with treatment duration: 15% within 12 months, 25% within 2 years.
- Switching occurred equally between patent and off-patent epoetins, not limited to reference and biosimilar pairs.
Conclusions:
- Switching between epoetins is linked to treatment duration.
- A significant proportion of switches involved epoetins not directly compared in clinical trials.
- Observed switching rates may support physician confidence in managing ESA transitions.
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