Bioanalysis for Biosimilars Development edition:e-book pages:Chapter-8
Monoclonal antibodies (MAs) are complex biotherapeutics as their molecular mechanism of action depends on multiple domains each contributing to the pharmacological and therapeutic properties of the molecule as well as to the safety profile. Consequently, biosimilar monoclonal antibodies constitute a unique class of biosimilars requiring specific guidelines for regulatory approval. An extensive comparative in vitro characterization to evaluate the biosimilarity of the various functional domains is required. Apart from typical protein analysis, evaluation of the glycosylation profile is of utmost importance. The exquisite species specificity of MAs precludes reliable in vivo nonclinical evaluations and means that adequately designed clinical studies are extremely critical to confirm the biosimilarity.