Translational Medicine

QPS Scientists Xun Wang & LingSing Chen publish editorial in Bioanalysis on the Challenges in Bioanalytical Assays for Biosimilars

Biosimilars are biological medicines that are similar but not identical to the existing reference biologics, which are generally complex large molecules. This incomplete overlap presents unique challenges in the development and validation of bioanalytical methods to evaluate both PK and immunogenicity for the purposes of demonstrating analytical similarity between reference and biosimilar agents.

Bioanalytical methods for biosimilar product development demand much consideration and planning before and during method development and validation. For one thing, the supply of drug and anti-drug antibodies should be determined from the beginning. Different manufacture lots of the reference standard should be selected, depending upon where the regulatory approval is targeted - the EU or the USA.

In PK methods, both the calibration standards and QCs from reference and biosimilar drugs are compared using experimental and statistical assessments for their parallelism and differences. The one-assay approach can be adopted only if analytical similarity has been established. In immunogenicity assays, the performance of the labeled drugs and cross reactivity of anti-drug antibodies are the critical factors to evaluate during the early method development stage, before the deciding upon the final approach.

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