Use of population approach non-linear mixed effects models in the evaluation of biosimilarity of monoclonal antibodies.

Reijers JA, van Donge T, Schepers FM, Burggraaf J, Stevens J

Population pharmacokinetic analyses (PPK) have been used to establish bioequivalence for small molecules and some biologicals. We investigated whether PPK could also be useful in biosimilarity testing for monoclonal antibodies (MAbs).