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Simponi (Golimumab) & Utilization

    Basic Details
    Last Updated
    Thursday, August 3, 2023
    Original Posting Date
    Health Outcome(s)
    Drug Use
    Meets requirements of FD&C Act Sec 505(o) prior to requiring a PMR
    Regulatory Determination / Use

    In May 2013, the FDA approved golimumab for ulcerative colitis with a post-market required (PMR) study to assess risk of lymphoma. In response to concerns about low enrollment in this study, the FDA conducted an analysis in Sentinel's Merative™ MarketScan® Research Databases using the Query Builder tool to understand if golimumab utilization in patients with ulcerative colitis (UC) was contributing to low patient enrollment. From January 2017 – December 2019, the relative frequency of anti-TNFα new-use episodes for UC in adults was 56%, 39%, and 5% for adalimumab, infliximab (including biosimilars), and golimumab, respectively. These data confirmed low utilization of golimumab and supported the FDA’s decision to discontinue further enrollment in the PMR study.