The changes necessary in the assessment of immunogenicity for the development of Biosimilars.

Immunogenicity knowledge and the analytical capabilities to characterize molecules have evolved within the last decade. This creates opportunities in Biosimilar development by applying new strategies to demonstrate similarity between a proposed Biosimilar to its Reference.Within Immunogenicity Risk Assessment for Biosimilars, in silico and in vitro immunogenicity assessment tools are being evaluated for their utility in Biosimilar development. An ISI including an Immunogenicity Risk Assessment is recommended for Biosimilars within the dossier of licensing applications to facilitate the review by Health Authorities and to explain the immunogenicity in conjunction with analytical and clinical data. Operational aspects should also be considered to refine immunogenicity testing of Biosimilars, e.g. S/N ratio and singlicate sample analysis.