Therapeutic Equivalence and the Generic Competition Paradox : The B.E. Journal of Economic Analysis & Policy

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The B.E. Journal of Economic Analysis & Policy

Editor-in-Chief: Jürges, Hendrik / Ludwig, Sandra

Ed. by Auriol , Emmanuelle / Brunner, Johann / Fleck, Robert / Mendola, Mariapia / Requate, Till / Zulehner, Christine / Schirle, Tammy


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Therapeutic Equivalence and the Generic Competition Paradox

1Deakin University

2Deakin University

3Deakin University

4Deakin University

Citation Information: The B.E. Journal of Economic Analysis & Policy. Volume 12, Issue 1, ISSN (Online) 1935-1682, DOI: 10.1515/1935-1682.3234, November 2012

Publication History

Published Online:
2012-11-12

This article offers supplementary material which is provided at the end of the article.

Abstract

Following the passage of the Waxman-Hatch Act (1984), FDA approval for a generic drug requires the establishment of bio-equivalence between the generic drug and an FDA approved branded drug. However, a large body of evidence in the medical community suggests that bio-equivalence does not guarantee therapeutic equivalence; in some instances the lack of therapeutic equivalence can lead to fatal consequences for patients switching to generic products. In this paper, we construct a simple model to analyze the implications of therapeutic non-equivalence between branded and generic drugs. We show, theoretically and empirically, that this distinction can provide a plausible explanation of the generic competition paradox.

Keywords: therapeutic equivalence; generic competition paradox

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