Congress Authorizes Abbreviated Regulatory Pathway for FDA Approval of Biological Products


With the enactment of health care reform legislation, Congress has authorized the Food and Drug Administration (“FDA”) to approve biological products through an abbreviated regulatory pathway that does not require such products to undergo full clinical testing. Although an abbreviated pathway has been in place for generic drug products under the Hatch-Waxman Amendments since 1984, Congress had not previously established an analogous scheme allowing for approval of so-called “follow-on biologics” or “biosimilars.”

This new regulatory framework is contained in the Biologics Price Competition and Innovation Act (the “Act”), which is included within the body of the Patient Protection and Affordable Health Care Act (H.R. 3590) that was signed into law by the President on March 23, 2010. While the new biosimilars legislation and the Hatch-Waxman Amendments share certain concepts, they also differ considerably. This reflects the distinct nature of the categories of products—biologics and drugs—regulated under each statute.

Major features of the new Act include the following...

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