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Characteristics of trials and regulatory pathways leading to US approval of innovative vs. non-innovative oncology drugs

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  • Vokinger, Kerstin Noëlle
  • Kesselheim, Aaron S.

Abstract

Successful first-generation drugs can be converted with small alterations to "second-generation drugs," which are cheaper to develop and may pose less financial risk for manufacturers due to already validated action mechanism and a well-defined consumer market.

Suggested Citation

  • Vokinger, Kerstin Noëlle & Kesselheim, Aaron S., 2019. "Characteristics of trials and regulatory pathways leading to US approval of innovative vs. non-innovative oncology drugs," Health Policy, Elsevier, vol. 123(8), pages 721-727.
    • Handle: RePEc:eee:hepoli:v:123:y:2019:i:8:p:721-727
    DOI: 10.1016/j.healthpol.2019.06.002
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    References listed on IDEAS

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    1. David Dranove & David Meltzer, 1994. "Do Important Drugs Reach the Market Sooner?," RAND Journal of Economics, The RAND Corporation, vol. 25(3), pages 402-423, Autumn.
    2. Hoekman, Jarno & Boon, Wouter, 2019. "Changing standards for drug approval: A longitudinal analysis of conditional marketing authorisation in the European Union," Social Science & Medicine, Elsevier, vol. 222(C), pages 76-83.
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    Cited by:

    1. Vokinger, Kerstin N. & Muehlematter, Urs Jakob, 2020. "Accessibility of cancer drugs in Switzerland: Time from approval to pricing decision between 2009 and 2018," Health Policy, Elsevier, vol. 124(3), pages 261-267.

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