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Senate Biologics Bill Draws Industry Ire

Law360 (March 27, 2009, 12:00 AM EDT) -- Bipartisan legislation introduced in the U.S. Senate that would create a regulatory process for the U.S. Food and Drug Administration to approve generic versions of biologic drugs is being lambasted by the biologic drug community, which says it would jeopardize patient safety.

Sens. Charles Schumer, D-N.Y., Susan Collins, R-Maine, Sherrod Brown, D-Ohio, Mel Martinez, R-Fla., Debbie Stabenow, D-Mich., and David Vitter, R-La., introduced S. 726, which would amend the Public Health Service Act to provide for the licensing of biosimilar and biogeneric biological products.

The proposal,...
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