Bioequivalence and Bioavailability Forum

AAPS members and [the Bioequivalence] focus group have proposed and organized sessions about harmonization of BE criteria for many years between regulatory agencies such as the Food and Drug Administration (FDA), the European Medicines Agency (EMA), and Health Canada (HC). De­spite this, recent regulatory changes have been somewhat disappointing as they still do not point in this direction. Recent examples are the new criteria for narrow therapeutic index or range drugs from FDA that are very different from what HC and EMA have now been requesting for many years. The recently published EMA BE guidance also points out new and exciting criteria being developed for modified release formulations, but some of them are, unfortunately, very different from what HC and FDA are requiring. This actually means that the scientific landscape driving regulatory changes and criteria is not black and white in the BE and biosimilarity field, but instead presents varying levels of gray where sometimes regulatory scientists will migrate to, but at the expense of har­mo­ni­za­tion between major regulatory jurisdictions. The BE focus group will continue to push for more har­mo­ni­za­tion of regulatory criteria and guidances, which makes sense in the current environment where companies have to develop drugs and biologics from a global point of view.