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October 25, 2018

FDA sets new record for generic drug approvals

Daily Briefing

    FDA set a new record for generic approvals in fiscal year (FY) 2018, according to data the agency released this month.

    The data show FDA approved 781 generic drugs in FY 2018, breaking the agency's previous record of 763 generic drug approvals in FY 2017.

    Of the generic drugs FDA approved in FY 2018, 137 were the first generics approved to compete with their brand name counterparts—compared with 54 first-time generic approvals in FY 2017. FDA said 12% of the generic drugs approved in FY 2018 were complex products, such as Teva Pharmaceuticals' generic version of Mylan's EpiPen and EpiPen Jr.

    The data also show FDA tentatively approved 190 generic drugs in FY 2018, compared with 174 generic drugs in FY 2017. According to BioPharama Dive, FDA issues tentative approvals for generic drugs before patents for their branded counterparts expire.


    FDA's approval of 137 first generic competitors is not likely to have a significant effect on drug prices, because drug prices typically come down once there is more than one generic competitor on the market, Axios' "Vitals" reports.

    FDA Commissioner Scott Gottlieb said, "We'll continue taking additional steps to help ensure patients have access to the drugs they need by making generic drug approval more efficient and predictable." He added, "We also will continue our focus on helping to bring more generic versions of complex drugs … to the market. In too many cases, there is no generic competition for these costly branded drugs even after they have lost their exclusivity protections."

    Gottlieb last week said FDA currently is seeking to harmonize U.S. and European regulations for generic drug approvals to allow drugmakers to bring products to both markets without having to meet different standards (Elvidge, BioPharma Dive, 10/12; Baker, "Vitals," Axios, 10/23; King, Washington Examiner, 10/11).

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