Anticompetitive Mergers — Pharmaceutical Buyouts as a Strategy for Maintaining Market Dominance

Tu SS, King J - New England Journal of Medicine

  • Innovation Incentives and Competition

Summary:

Pharmaceutical “killer acquisitions,” in which incumbent firms buy out smaller competitors to shelve or delay their products, pose a threat to competition and innovation that current antitrust frameworks under the Hart-Scott-Rodino Act are poorly equipped to catch. The authors recommend coordinated legislative and regulatory reforms to better protect competition and patient interests, including lowering notification thresholds for concentrated industries, accounting for intangible assets like patents in merger valuations, and applying heightened scrutiny to acquisitions involving overlapping products.

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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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