Seeking Accelerated Biosimilar Characterization

The development of a biosimilar product requires extensive structural and functional characterization at many stages. At the functional level, pharmacologic activity should be evaluated by appropriate in-vitro and/or in-vivo assays in a comparative sense, to provide evidence that the activity and potency are similar, supporting data from structural characterization.

These in-vitro and in-vivo potency assays, however, can be expensive and time consuming, with readouts that are often far downstream of the initial drug/target interaction. Cell-based assays, with a readout proximal to the initial target, can be an attractive alternative. The authors describe the qualification of an assay with applications for investigating functional comparability of an originator and biosimilar drug.

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