Can ADA be considered biomarkers?

The basis of applying a risk-based approach to immunogenicity evaluation of therapeutic proteins shares, from a scientific point-of-view, remarkable similarities to the definition of biomarkers conditions of used (CoU)

Over the past 20 years, anti-drug antibodies (ADA) have been used to address the immunogenicity of therapeutic proteins during drug development. Actually, the clinical use and interpretation of immunogenicity data can fall under many of the BEST biomarker classification, to name a few: predictive, prognostic, PD/Response,safety, or susceptibility/risk.

New biotherapeutic modalities are challenging the current immunogenicity testing paradigm. That is why immunogenicity prediction and risk-based approaches are so relevant to identify the optimal immunological markers and validate fit-for-purpose analytical methods so the key markers can be analyzed side-by-side clinical outcomes.