FDA Starts On Path To Approving Biosimilars

Law360, New York (November 2, 2010, 6:42 PM EDT) -- As it begins the lengthy process of approving the first generic versions of biologic drugs, the U.S. Food and Drug Administration has been warned by experts that it will take considerable effort to balance patient safety with cost control and incentives to innovate with healthy competition.

During the first day of a two-day public hearing that will include testimony from pharmaceutical companies, advocacy groups and doctors, the FDA was told on Tuesday that it must figure out what it hopes to accomplish by implementing H.R. 3590,...
To view the full article, register now.