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

Optimum use of generic products would require equivalence, not only in terms of quality, safety and efficacy in clinical studies, but also patient acceptability in order not to jeopardize treatment success due to non-adherence which would de facto limit the potential cost saving anticipated by their use. Although acceptability is a requirement for the authorisation of paediatric innovator products, our survey of EU regulatory authorities uncovered 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 focus on unifying guidance for the development and scrutiny of generics should include acceptability alongside the other factors being considered for harmonization.