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Fifth Amendment › FDA Approval

Patterson Belknap Webb & Tyler LLP

FDA Says BPCIA Poses No Fifth Amendment Taking for Innovator Biologics Submitted Prior to Its Enactment

Patterson Belknap Webb & Tyler LLP on

On the same day that FDA approved the first biosimilar of Humira, the fourth biosimilar to be approved in the U.S., it also denied a citizen petition filed by Abbott Laboratories (now AbbVie) requesting that FDA not accept...more

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