Show Summary Details

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.

You are not authenticated to view the full text of this chapter or article.

Elgaronline requires a subscription or purchase to access the full text of books or journals. Please login through your library system or with your personal username and password on the homepage.

Non-subscribers can freely search the site, view abstracts/ extracts and download selected front matter and introductory chapters for personal use.

Your library may not have purchased all subject areas. If you are authenticated and think you should have access to this title, please contact your librarian.


Further information

or login to access all content.