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Integrated Summary of Immunogenicity

Meaning

The Integrated Summary of Immunogenicity (ISI) is a comprehensive regulatory document submitted to health authorities, such as the FDA or EMA, that synthesizes all immunogenicity data collected throughout the clinical development of a biological product, including recombinant hormones or peptides. This document meticulously evaluates the incidence, titer, and characteristics of anti-drug antibodies (ADA), assesses their impact on pharmacokinetics, pharmacodynamics, efficacy, and safety, and provides a final risk assessment. The ISI is a mandatory component of a Biologics License Application (BLA) or a Marketing Authorization Application (MAA), providing a holistic view of the drug’s interaction with the patient’s immune system. Its purpose is to ensure the long-term safety and predictable performance of the therapeutic agent.