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Characterization of Use of Biologics and Biosimilars in the Sentinel Distributed Database: A Descriptive Analysis

    Basic Details
    Date Posted
    Status
    Complete
    Medical Product
    Neupogen (filgrastim)
    Remicade (infliximab)
    Health Outcome(s)
    biosimilar use
    Description

    The purpose of this study was to understand how biologics, their biosimilars and related drugs are coded for reimbursement, and therefore appear in claims data. The medications of interest were the biologic Neupogen, its biosimilar Zarxio, and related drugs Granix and Neulasta; and the biologic Remicade and its biosimilars Inflectra and Renflexis. This study consists of two reports.

    • Report 1: This report contains estimates of utilization of medications of interest in the Sentinel Distributed Database (SDD).
    • Report 2: This report contains estimates of utilization of medications of interest in the SDD, distribution of their days supplied per dispensing, and descriptive statistics for gaps between treatment episodes.

    The study period for Report 1 includes data from January 1, 2015, to January 31, 2018. The study period for Report 2 includes data from January 1, 2015, to May 22, 2018. We distributed this request to 17 Sentinel Data Partners on June 29, 2018.

    Additional Details
    FDA Center
    CDER
    Time Period
    January 1, 2015 - January 31, 2018; January 1, 2015 - May 22, 2018
    Analysis Type
    Descriptive
    Population / Cohort
    All individuals
    Data Sources
    Sentinel Distributed Database (SDD)