BIO Submits "Guideline on immunogenicity assessment of monoclonal antibodies intended for in vivo clinical use" Comments to the European Medicines Agency (EMA)

BIO provides specific comments and requests clarifications on the text of the Guideline regarding the variability of immunogenicity, approaches for predicting and reducing immunogenicity, clinical consequences of immunogenicity, problems with screening and confirmatory assays, assessing the neutralizing capacity of antibodies, as well as the risk-based approach.