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Richard P Rozek

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.

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Richard P. Rozek and George G. Korenko