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.

In particular, manufacturers of the branded biologics have raised safety and public...
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