Effective In Vitro Bioanalytical Assays for Comparing Pharmacodynamics of Biosimilar Monoclonal Antibodies

The rise in the development of biosimilar therapeutics has caused increasing demand for new approaches for precise, sensitive, accurate bioanalysis. This white paper describes how a combination of the biopharmaceutical market, regulatory guidelines and the molecular characteristics of biologics has inspired the development of novel ligand-binding assays (specifically, flow cytometry and surface plasmon resonance) that may streamline evaluation of biosimilars.