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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.
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    Cited by:

    1. Herr, A. & Suppliet, M., 2011. "Co-Payment Exemptions and Reference Prices: an Empirical Study of Pharmaceutical Prices in Germany," Health, Econometrics and Data Group (HEDG) Working Papers 11/18, HEDG, c/o Department of Economics, University of York.
    2. Suppliet, Moritz & Herr, Annika, 2016. "Cost-Sharing and Drug Pricing Strategies : Introducing Tiered Co-Payments in Reference Price Markets," Discussion Paper 2016-040, Tilburg University, Center for Economic Research.
    3. Elissa Philip Gentry, 2019. "Empirical evidence of risk penalties for NTI Drugs," Journal of Risk and Uncertainty, Springer, vol. 58(2), pages 219-244, June.
    4. Vijay Mohan & Munirul Nabin, 2023. "A note on disease burden and pharmaceutical R&D," Australian Economic Papers, Wiley Blackwell, vol. 62(4), pages 633-649, December.

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