Immunogenicity of biosimilar monoclonal antibodies

Biosimilar monoclonal antibodies (mAbs) are making their way onto the drug market. Because these are complex molecules in terms of structure and function, assessing similarity between originator and biosimilar mAb is challenging. This review discusses the hallmarks of similarity testing between originator products and mAb biosimilars in terms of product quality attributes, non-clinical and clinical studies, with a focus on immunogenicity. Sparse data on immunogenicity of biosimilar mAb products is given.