Qualification of an Assay with Applications for Investigating Functional Comparability of an Originator and Biosimilar

The development of a biosimilar product requires extensive characterization at many stages. At the functional level, pharmacologic activity should be evaluated by appropriate in vitro and/or in vivo assays. However, these potency assays can be expensive and time consuming.
 
This paper reviews the qualification of cell-based assays for functional comparability analysis that provide an attractive alternative to more expensive and time-consuming assays.