The FTC's Stance On Generic Biologics

Law360, New York (July 9, 2009, 12:00 AM EDT) -- This year marks the 25th anniversary of the Hatch-Waxman Act in the United States, which created a pathway for generic drugs by means of an abbreviated version of a New Drug Application for small molecule drugs regulated by the Federal Food, Drug and Cosmetic Act.

However, no pathway currently exists in the United States for generic biologics, or "follow-on biologics" ("FOBs"), by means of an abbreviated version of a Biologics License Application ("BLA") for larger and more complex biological molecules regulated by the Public Health Service...
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