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A survey of pharmacokinetic bioanalytical methods in biosimilar biological license applications for the assessment of target and antidrug antibody effects
- Source :
- Bioanalysis. 13(17)
- Publication Year :
- 2021
-
Abstract
- 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.
- Subjects :
- Bioanalysis
business.industry
Antidrug antibody
Clinical Biochemistry
Therapeutic protein
Biosimilar
General Medicine
Pharmacology
Method development
Antibodies
Analytical Chemistry
Medical Laboratory Technology
Pharmacokinetics
Drug Discovery
Medicine
Humans
General Pharmacology, Toxicology and Pharmaceutics
business
License
Biosimilar Pharmaceuticals
Subjects
Details
- ISSN :
- 17576199
- Volume :
- 13
- Issue :
- 17
- Database :
- OpenAIRE
- Journal :
- Bioanalysis
- Accession number :
- edsair.doi.dedup.....1fa1aa50c3325504c6174c6c98269d40