Understanding Utilization Patterns of Biologics and Biosimilars in the United States to Support Postmarketing Studies of Safety and Effectiveness

Project Title Understanding Utilization Patterns of Biologics and Biosimilars in the United States to Support Postmarketing Studies of Safety and Effectiveness
Date
Wednesday, December 11, 2019
Location
Description

The purpose of this manuscript was to describe utilization of filgrastim and infliximab, the first two products with biosimilars approved in the United States. The authors concluded that use of biosimilar filgrastim has increased in the United States, but infliximab biosimilar use remains low. Data on identification of biosimilars in claims data and observed gaps between exposure episodes can be used to support drug safety studies of biosimilars.

Medical Product
filgrastim
infliximab
Corresponding Author

Sarah K. Dutcher, Office of Surveillance and Epidemiology, Center for Drug Evaluation and Research, Food and Drug Administration, Silver Spring, Maryland.
Email: sarah.dutcher@fda.hhs.gov

Authors

Sarah K. Dutcher, Elnara Fazio‐Eynullayeva, Efe Eworuke, Amanda Carruth, Elizabeth C. Dee, Michael D. Blum, Michael D. Nguyen, Sengwee Toh, Catherine A. Panozzo, Jennifer G. Lyons

Data Sources
Sentinel Distributed Database (SDD)
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