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Therapeutic Equivalence and the Generic Competition Paradox


  • Nabin Munirul Haque

    () (Deakin University)

  • Mohan Vijay

    () (Deakin University)

  • Nicholas Aaron

    () (Deakin University)

  • Sgro Pasquale M.

    () (Deakin University)


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

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    References listed on IDEAS

    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.
    3. Perloff, Jeffrey M. & Suslow, Valerie Y. & Seguin, Paul J., 1995. "Higher Prices from Entry: Pricing of Brand-Name Drugs," Competition Policy Center, Working Paper Series qt75g4k1nt, Competition Policy Center, Institute for Business and Economic Research, UC Berkeley.
    4. F. M. Scherer, 1993. "Pricing, Profits, and Technological Progress in the Pharmaceutical Industry," Journal of Economic Perspectives, American Economic Association, vol. 7(3), pages 97-115, Summer.
    5. Levin, Andrew & Lin, Chien-Fu & James Chu, Chia-Shang, 2002. "Unit root tests in panel data: asymptotic and finite-sample properties," Journal of Econometrics, Elsevier, vol. 108(1), pages 1-24, May.
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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.

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