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Yes, immunogenicity is technically monitored in clinical
trials. Anti-drug antibody (ADA) testing is performed in
many phase III studies. But in practice, it's treated as a side
metric, not a core determinant of approval. If
immunogenicity doesn't clearly correlate with adverse
events or immediate loss of efficacy within the trial
window, it’s often treated as background noise.
Why? Because demanding rigorous, long-term immune
tolerance data would fundamentally change the pace and
economics of drug development. It would:
• Delay approvals by extending trials well beyond
typical endpoints—into years, not months.
• Increase development costs by requiring more
patients, more testing, more long-term monitoring,
and potentially new biomarker platforms.
• Shrink the market pipeline, as fewer drugs would
meet stricter durability thresholds, and more would
be disqualified before reaching commercial
viability.
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