Reflections on Historical, Scientific, and Legal Issues Relevant to Designing Approval Pathways for Generic Versions of Recombinant Protein-Based Therapeutics and Monoclonal Antibodies

May 2005

60 Food and Drug Law Journal 143-260 (2005).

The Food and Drug Administration (FDA) approves generic drugs for marketing in the United States. Thus, FDA also necessarily bears the final responsibility for mediating the constant war between the research-based pharmaceutical industry and the generic drug industry. Significant public policy concerns weigh in this balance, namely future innovation and the development of new therapeutics versus less expensive drug costs and increased access to medicines. The next chapter in this war—already begun—is the conflict over generic biotechnology products. This analysis aims to construct an authoritative historical background on both the relevant law and science; analyze cases and FDA interpretations relevant to the regulation of protein biologics and their possible generic approval; and offer scientific insights useful to Congress or FDA in implementing a scheme of generic protein-based therapeutics.


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