Recommendations for the Development and Validation of Neutralizing Antibody Assays in Support of Biosimilar Assessment

Author:

Gouty D.,Cai C. C.,Cai X. Y.,Kasinath A.,Kumar V.,Alvandkouhi S.,Yang J.,Pederson S.,Babbitt B.,Peritt D.,Rudy A.,Koppenburg V.,Dasilva A.,Ullmann M.,Liu S.,Satterwhite C.

Publisher

Springer Science and Business Media LLC

Subject

Pharmaceutical Science

Reference31 articles.

1. U.S. Department of Health and Human Services. Food and Drug Administration. Center for Drug Evaluation and Research (CDER). Center for Biologics Evaluation and Research (CBER). Quality considerations in demonstrating biosimilarity to a reference protein product. April 2015.

2. U.S. Department of Health and Human Services. Food and Drug Administration. Center for Drug Evaluation and Research (CDER). Center for Biologics Evaluation and Research (CBER). Scientific considerations in demonstrating biosimilarity to a reference product. April 2015.

3. European Medicines Agency. EMEA/CHMP/BMWP/42832/2005 Rev1. Guideline on similar biological medicinal products containing biotechnology-derived proteins as active substance: non-clinical and clinical.

4. Marini JC, Anderson M, Cai X-Y, Chappell J, Coffey T, Gouty D, et al. systematic verification of bioanalytical similarity between a biosimilar and a reference biotherapeutic: committee recommendations for the development and validation of a single ligand-binding assay to support pharmacokinetic assessments. AAPS J. 2014;16(6):1149–58.

5. Mok CC, van der Kleij D, Wolbink GJ. Drug levels, anti-drug antibodies, and clinical efficacy of the anti-TNFα biologics in rheumatic diseases. Clin Rheumaatol. 2013;32(10):1429–35. https://doi.org/10.1007/s10067-013-2336-x .

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