Acceptability of generic versus innovator oral medicines: not only a matter of taste

Drug Discov Today. 2021 Feb;26(2):329-343. doi: 10.1016/j.drudis.2020.11.008. Epub 2020 Nov 17.


Optimum use of generic products would require equivalence, not only in terms of quality, safety, and efficacy in clinical studies, but also patient acceptability to not jeopardize treatment success because of non-adherence which would de facto limit the potential cost saving anticipated by their use. Although acceptability is a requirement for the authorization of pediatric innovator products, a survey of European Union (EU) regulatory authorities showed that few have a formal process for assessing patient acceptability of generic products during the registration processes. The current International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) focus on unifying guidance for the development and scrutiny of generics but should include acceptability alongside the other factors being considered for harmonization.

Publication types

  • Comparative Study
  • Review

MeSH terms

  • Administration, Oral
  • Drug Approval / legislation & jurisprudence*
  • Drug Development / methods*
  • Drugs, Generic / administration & dosage*
  • Drugs, Generic / adverse effects
  • Drugs, Generic / standards
  • European Union
  • Humans
  • Internationality
  • Patient Acceptance of Health Care
  • Taste
  • Therapeutic Equivalency


  • Drugs, Generic