Using real-world data to evaluate biosimilar switching
- PMID: 31692176
- DOI: 10.1002/pds.4899
Using real-world data to evaluate biosimilar switching
Comment on
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Methodologic considerations for noninterventional studies of switching from reference biologic to biosimilars.Pharmacoepidemiol Drug Saf. 2020 Jul;29(7):757-769. doi: 10.1002/pds.4809. Epub 2019 Jul 12. Pharmacoepidemiol Drug Saf. 2020. PMID: 31298463 Review.
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References
REFERENCES
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- Desai RJ, Kim SC, Curtis JR, et al. Methodologic considerations for non-interventional studies of switching from reference biologic to biosimilars. Pharmacoepidemiol Drug Saf. 2019. https://doi.org/10.1002/pds.4809
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- Drugs@FDA: FDA approved drug products. 2019. Accessed July 11, 2019, at https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm.
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- Christl LA, Woodcock J, Kozlowski S. Biosimilars: the US regulatory framework. Annu Rev Med. 2017;68(1):243-254.
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- Dougherty MK, Zineh I, Christl L. Perspectives on the current state of the biosimilar regulatory pathway in the United States. Clin Pharmacol Ther. 2018;103(1):36-38.
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- Food and Drug Administration. Scientific considerations in demonstrating biosimilarity to a reference product: guidance for industry. April 2015.
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