Bill Aims To Create Approval Process For Biosimilars

Law360, New York (March 11, 2009, 12:00 AM EDT) -- A bipartisan group of lawmakers has introduced a bill that would create a regulatory process allowing the U.S. Food and Drug Administration to approve affordable generic versions of biologic drugs.

H.R. 1427, the “Promoting Innovation and Access to Life-Saving Medicine Act,” aims to give the FDA the power to authorize an approved copy of a biologic drug, and assure consumers that it is just as safe as the original product. It was introduced by Rep. Henry Waxman, D-Calif., chairman of the House Committee on Energy and...
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