The panel voted 26-0 that ABP 501, Amgen’s cheaper version of Humira, was highly similar in safety and efficacy to North Chicago, Ill.-based AbbVie’s drug.
The panel also said that results from ABP 501’s drug trials could be extrapolated for other conditions that Humira is approved to treat — like Crohn’s disease and ulcerative colitis — and that the new drug should be approved to treat these additional conditions as well.
While the FDA is not compelled to follow the advisory committee’s advice, it typically does.
The panel’s findings were consistent with a preliminary review of the drug published by FDA scientists last Friday.
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Humira to face competition from biosimilars
GAO: Fewer new drug shortages, while ongoing shortages remain steady
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