The researchers suggest their findings support the position that bioequivalence for tacrolimus translates from healthy volunteers to recipients of a kidney or liver transplant and provides evidence that generic products bioequivalent with the innovator product are also bioequivalent to each other.
A perspective notes that “this study is a significant achievement, providing good evidence of bioequivalence between twice-daily formulations of tacrolimus. It accounts for within-patient variability in drug exposure over time in ways that have not previously been adequately dealt with in the literature. Given the importance of consistent dosing with optimal immunosuppression and the well-documented economic barriers to doing so in different settings, this high level of assurance for the use of generic formulations will not only improve value derived across healthcare systems but, crucially, also improve individual patient-level outcomes in the long-term and patient access to treatment across a range of healthcare economies.”