Occurrence of Selected Biological Generic Drug Products

    Basic Details
    Date Posted
    Thursday, October 10, 2013
    Status
    Complete
    Medical Product
    adalimumab
    darbepoetin alfa in albumin solution
    darbepoetin alfa in polysorbate
    epoetin alfa
    filgrastim
    infliximab
    interferon beta-1A
    interferon beta-1A/albumin
    interferon beta-1B
    pegfilgrastim
    rituximab
    somatropin
    trastuzumab
    Description

    Summary table assessment of 13 selected biological generic drug products, including epoetin alfa, darbepoetin alfa in albumin solution, darbepoetin alfa in polysorbate, interferon beta-1A, interferon beta-1A/albumin, interferon beta-1B, pegfilgrastim, somatropin, rituximab, infliximab, adalimumab, trastuzumab, and filgrastim in the Mini-Sentinel Distributed Database. Results were generated using the Mini-Sentinel Distributed Query Tool and the Dispensing Summary Table.Summary tables are precompiled stratified counts. Queries were executed in July 2012. This report includes data from 16 Data Partners.

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    Additional Details
    FDA Center
    CBER
    Time Period
    2010
    Study Type
    Summary Table
    Assessment Type
    Exploratory Analyses
    Data Sources
    Mini-Sentinel Distributed Database (MSDD)