Volume: 2 Issue: 4

Queen Mary Journal of Intellectual Property

Economics as a guide to developing public policies for biosimilar pharmaceutical products

Richard P Rozek * *

Keywords: biosimilars, generic, regulation, health care, costs, marketing

Abstract

Throughout the world, public policies are evolving with regard to biosimilar (large molecule) pharmaceutical products. The associated issues involve scientific, political, legal, and economic questions. This paper examines the state of the economic debate in the US as the US Food and Drug Administration formulates its process for approving biosimilar products. Due to differences in biosimilar and small molecule products, regulatory experience gained from the success of generic small molecule products in the US and elsewhere is not necessarily a useful guide.

Author Notes

Current and former staff members of National Economic Research Associates, Inc (NERA) provided valuable inputs into this paper. Some of information incorporated in this paper is based on research funded by a research-based pharmaceutical company. The opinions are those of the author and do not necessarily reflect the views of any other person at NERA or any research-based pharmaceutical company.

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