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Expert Analysis

Following Up On Follow-On Biologics

Law360, New York (December 2, 2013, 3:23 PM EST) -- Five years ago, the Federal Trade Commission waded into the debate regarding the benefits and potential competition issues posed by the introduction of "follow-on biologics." Now, some three years after Congress provided a pathway for approval of such products, the FTC is jumping back in, as to date no follow-on biologic has been approved by the U.S. Food and Drug Administration, and new issues have emerged that could delay the introduction of such products....

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