Follow-on Biologics Proposals v. Hatch-Waxman: What the FOB Market Might Look Like

Posted 01 January 2008 | By

Members of Congress and biotechnology stakeholders have been hotly debating proposals to establish a new abbreviated approval pathway for follow-on versions of innovator biotechnology products, generally referred to as follow-on biologics (FOBs). The leading legislative proposal to date is the Biologics Price Competition and Innovation Act of 2007 (S 1695). Congress has not yet enacted S 1695 or any of the other proposals, and all remain subject to modification going forward. Nonetheless, the proposals demonstrate that the likely legislative scheme for FOBs will differ markedly from that for generic small molecule drugs under the Hatch-Waxman Act. This in turn will shape a very different business model for FOBs than exists for traditional generic drug products. These differences are driven by the complexity of manufacturing biologics, the limitations in characterizing and comparing biologic products, and the resulting need for distinct FOB approval and interchangeability standards to help ensure product safety and protect the public health. While we may see adoption of an abbreviated approval scheme for FOBs in the near future, true "generic biologics" are not yet on the horizon.1


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