Table 3.

Examples of the types of analyses that may be used to demonstrate similarity of a potential biosimilar to the originator biologic

Analysis	Type of similarity	Example of methods employed
Protein characterization	Structural	Liquid chromatography and mass spectrometry peptide mapping38,39
Biological activity functional bioassay	Functional	Cell-based binding affinity (eg, tumor necrosis factor binding for infliximab biosimilars)38
In vivo toxicity and toxicokinetics	Nonclinical	Repeat-dose toxicity study in a relevant species and including toxicokinetic measurements10,14
Clinical PK	Clinical	Comparative human PK study employing a sensitive population, dose(s), and route of administration that allow detection of whether differences in PK exist10,14,15
Clinical efficacy	Clinical	Comparative efficacy for the potential biosimilar and originator using sensitive clinical end points (usually designed as an equivalence study)10,14,15
Clinical safety	Clinical	Comparative safety including immunogenicity10,14,15

Abbreviation: PK, pharmacokinetics.