Harmonisation of global bioequivalence standards - where do we stand?

Bioequivalence studies are the most frequently designed and conducted clinical trials and primarily, but not only an essential element in the generic drug approval process. Also for other regulatory conditions bioequivalence plays an essential role, e.g., in case of modifications of formulations and/or variations in the manufacturing process during product’s life-cycle. While in the 1990s of the last millennium the definition of science-based requirements for appropriate bioequivalence assessment was of primary interest, harmonisation of global BE regulations became the major goal during recent years. Following several temporary attempts EUFEP’s Global Bioequivalence Harmonisation Initiative brought a decisive breakthrough in this context. Only with this initiative the way was paved for the development of the first ICH bioequivalence guideline (M13A) which will then be valid worldwide. While broad consensus in the majority of detailed bioequivalence requirements could be achieved meanwhile between the global health authorities, there are still few but important aspects unresolved waiting for experimental evidence as basis for science-driven regulations. Closing this gap is an important challenge for scientists in industry as well as in academia.