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Revised 2 October 2003.

Abstract

There are sufficient legal and scientific precedents to support positions ranging from arguments against the approval of any 'generic' biologic to arguments that support the position that existing Food and Drug Administration (FDA) precedents permit the approval of a generic biologic. While it seems highly likely that at some point there will be a legally and scientifically acceptable construct for the approval of generic biologics, given the diverse opinions and varied interests of the US Congress, the FDA, the pharmaceutical and biotechnology industries, health service providers, insurers, consumers and the scientific community with regard to generic biologics, it is difficult to determine what such a construct will entail, or when it might be implemented. The only certainty is that there are presently no absolutes regarding this issue, either legally or scientifically. This paper seeks to trace past and current events that are quickly culminating to set the stage for a war over generic biologics, and which may offer some insight into the agency's thinking on their uncertain future.