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Comment
. 2020 Jul;29(7):814-816.
doi: 10.1002/pds.4899. Epub 2019 Nov 6.

Using real-world data to evaluate biosimilar switching

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Comment

Using real-world data to evaluate biosimilar switching

Sarah K Dutcher et al. Pharmacoepidemiol Drug Saf. 2020 Jul.
No abstract available

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REFERENCES

    1. 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
    1. Drugs@FDA: FDA approved drug products. 2019. Accessed July 11, 2019, at https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm.
    1. Christl LA, Woodcock J, Kozlowski S. Biosimilars: the US regulatory framework. Annu Rev Med. 2017;68(1):243-254.
    1. 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.
    1. Food and Drug Administration. Scientific considerations in demonstrating biosimilarity to a reference product: guidance for industry. April 2015.

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