2019 PharmSci 360
A phase 1, single-dose, crossover study was conducted to evaluate the pharmacokinetic equivalence of two biological products. The epoetin alfa-epbx single-dose vial (SDV) formulation, a biosimilar licensed by the US Food and Drug Administration (reference product), was compared with the epoetin alfa-epbx multiple-dose vial (MDV) formulation, a proposed biosimilar (test product). In this study, the reference product is a biosimilar rather than the originator biological product. The approach to expanding a formulation of a licensed biosimilar will be differentiated from the regulatory pathway used to establish biosimilarity. The relevance of healthy subjects in a phase 1 human pharmacokinetics study comparing different formulations of a biosimilar will be discussed, in addition to the pharmacokinetic equivalence between the epoetin alfa-epbx SDV formulation and the epoetin alfa-epbx MDV formulation.