The Challenges and Opportunities of Using Large Administrative Claims Databases for Biosimilar Monitoring and Research in the United States

Author:

Panozzo Catherine A.,Haynes Kevin

Publisher

Springer Science and Business Media LLC

Subject

General Medicine

Reference60 articles.

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2. Food and Drug Administration, Center for Drug Evaluation and Research. Purple book: lists of licensed biological products with reference product exclusivity and biosimilarity or interchangeability evaluations. 2017. https://www.fda.gov/Drugs/DevelopmentApprovalProcess/HowDrugsareDevelopedandApproved/ApprovalApplications/TherapeuticBiologicApplications/Biosimilars/ucm411418.htm . Accessed 26 Sept 2017.

3. Holzmann J, Balser S, Windisch J. Totality of the evidence at work: the first U.S. biosimilar. Expert Opin Biol Ther. 2016;16(2):137–42. https://doi.org/10.1517/14712598.2016.1128410 .

4. Ledford H. First biosimilar drug set to enter US market. Nature. 2015;517(7534):253–4. https://doi.org/10.1038/517253a .

5. Food and Drug Administration CfDEaR. CDER list of licensed biological products. 2017. https://www.fda.gov/downloads/Drugs/DevelopmentApprovalProcess/HowDrugsareDevelopedandApproved/ApprovalApplications/TherapeuticBiologicApplications/Biosimilars/UCM560162.pdf . Accessed 2016 Sept 2017.

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1. Pharmacovigilance of Innovator Biologics and Biosimilars;Biologics, Biosimilars, and Biobetters;2020-12-30

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