Legislators Introduce Follow-On Biologics Bill

Law360, New York (March 14, 2008, 12:00 AM EDT) -- A bill proposed by two members of the U.S. House of Representatives to create a pathway for generic or follow-on biologic drugs similar to the abbreviated new drug application for conventional generic drugs has, unsurprisingly, divided the pharmaceutical industry.

Reps. Anna G. Eshoo (D-Calif.) and Joe Barton (R-Texas) introduced the Pathway for Biosimilars Act, (H.R. 5629) on Thursday. The bill would create a regulatory pathway for U.S. Food and Drug Administration approval of follow-on biologics.

Eschoo said the bill would allow the FDA to decide whether...
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