Defining “Innovativeness” in Drug Development: A Systematic Review

Kesselheim AS, Wang B, Avorn J - Clinical Pharmacology & Therapeutics

  • Innovation Incentives and Competition

Summary:

This systematic review of 42 studies found that conclusions about whether pharmaceutical innovation is declining depend critically on the measurement method used: studies using simple drug approval counts were more likely to find favorable innovation trends, while studies using other measures of innovation were more likely to find unfavorable trends or reach no conclusion. The ongoing debate about pharmaceutical innovation trends reflects fundamental disagreements about how to define and measure innovativeness in drug development, necessitating clearer methodological consensus.

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Recent Work from PORTAL

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The Impact of Semantics in Medicines Regulation

Costa E, Kesselheim AS - Journal of Law, Medicine, & Ethics

  • Innovation Incentives and Competition
  • Regulation and Clinical Evidence
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Delisted Patents on Pharmaceuticals, 1998-2024

Kirby-Rivera L, Feldman WB, Kim M, Kosmopoulou G, Kesselheim AS, Tu SS - Journal of Law, Medicine, & Ethics

  • Innovation Incentives and Competition
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Delays in Access to Generic Semaglutide Point to Key Missing Pieces in Canada’s Drug Approval System

Eisenkraft Klein D, Kesselheim AS - Health Policy

  • Innovation Incentives and Competition
  • Regulation and Clinical Evidence
Canada approved its first generic semaglutide nearly four months after market exclusivity expired, with delays arising from the absence of clear standards for demonstrating equivalence between fully synthetic generics and the brand-name product. Regulators should publish equivalence standards so manufacturers can build the required evidence into their initial submissions, helping lower-cost alternatives reach patients sooner.
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