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Therapeutic Equivalence and the Generic Competition Paradox

Author

Listed:
  • Nabin Munirul Haque

    (Deakin University)

  • Mohan Vijay

    (Deakin University)

  • Nicholas Aaron

    (Deakin University)

  • Sgro Pasquale M.

    (Deakin University)

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.

Suggested Citation

  • Nabin Munirul Haque & Mohan Vijay & Nicholas Aaron & Sgro Pasquale M., 2012. "Therapeutic Equivalence and the Generic Competition Paradox," The B.E. Journal of Economic Analysis & Policy, De Gruyter, vol. 12(1), pages 1-26, November.
    • Handle: RePEc:bpj:bejeap:v:12:y:2012:i:1:n:51
    DOI: 10.1515/1935-1682.3234
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    References listed on IDEAS

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    1. Ferrara, Ida & Kong, Ying, 2008. "Can health insurance coverage explain the generic competition paradox?," Economics Letters, Elsevier, vol. 101(1), pages 48-52, October.
    2. Ferrara, Ida & Missios, Paul, 2012. "Pricing of drugs with heterogeneous health insurance coverage," Journal of Health Economics, Elsevier, vol. 31(2), pages 440-456.
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    Cited by:

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