Journal
BIOANALYSIS
Volume 13, Issue 17, Pages 1323-1332Publisher
FUTURE SCI LTD
DOI: 10.4155/bio-2021-0116
Keywords
biosimilars; clinical; BLA; method development; matrix effects
Funding
- Oak Ridge Institute for Science and Education (ORISE) Funding Source: Medline
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The survey found that most pharmacokinetic methods can accurately measure free or partial-free TPs, but evaluation of antidrug antibody effects is limited. Measuring biologically active forms of TP is more relevant to clinical responses and important for biosimilarity assessments.
The presence of circulating targets and antidrug antibodies can influence the ability of a bioanalytical method to measure therapeutic protein (TP) concentration relevant to exposure-response evaluations. This project surveyed biosimilar submissions for their bioanalytical methods. Survey results revealed that 97% of pharmacokinetic methods designed to measure theoretically free or partial-free TPs with respect to target indeed measured free or partial-free TPs when considering experimental testing results for target effects. Antidrug antibody effect is less often evaluated. The observed trend of measuring biologically active forms of TP is consistent with the scientific understanding that pharmacokinetics of biologically active forms is more likely to be relevant to the clinical responses and evaluation of clinically meaningful differences to contribute to biosimilarity assessments.
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