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

    Basic Details
    Wednesday, December 11, 2019
    Medical Product

    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.


    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

    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