Biologics Legislation In The 111th Congress

Law360 (April 6, 2009, 12:00 AM EDT) -- Two bills have been introduced in the House that aim to create an FDA approval process for follow-on biologics similar to that established for generic drugs in the Hatch-Waxman Act of 1984.

The first bill, H.R. 1427, the “Promoting Innovation and Access to Life-Saving Medicine Act”, outlines an approval process that is highly favorable to follow-on biologic companies, whereas the second bill, H.R. 1548, the “Pathway for Biosimilars Act”, stakes out a position somewhat more favorable to the innovator biologics industry. A new law could take...
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