Therapeutic equivalence and the generic competition paradox

Nabin, Munirul Haque, Mohan, Vijay, Nicholas, Aaron and Sgro, Pasquale 2012, Therapeutic equivalence and the generic competition paradox, B.E. journal of economic analysis and policy, vol. 12, no. 1, Article 51, pp. 1-26, doi: 10.1515/1935-1682.3234.

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Title Therapeutic equivalence and the generic competition paradox
Author(s) Nabin, Munirul HaqueORCID iD for Nabin, Munirul Haque
Mohan, Vijay
Nicholas, AaronORCID iD for Nicholas, Aaron
Sgro, PasqualeORCID iD for Sgro, Pasquale
Journal name B.E. journal of economic analysis and policy
Volume number 12
Issue number 1
Season Article 51
Start page 1
End page 26
Total pages 26
Publisher Walter de Gruyter GmbH & Co. KG
Place of publication Berlin, Germany
Publication date 2012-11
ISSN 1935-1682
Keyword(s) therapeutic equivalence
generic competition paradox
Summary 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.
Language eng
DOI 10.1515/1935-1682.3234
Field of Research 140209 Industry Economics and Industrial Organisation
Socio Economic Objective 970114 Expanding Knowledge in Economics
HERDC Research category C1 Refereed article in a scholarly journal
Copyright notice ©2012, Walter de Gruyter GmbH & Co. KG
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Created: Wed, 28 Nov 2012, 15:19:49 EST by Beatrice Fitzgerald

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