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like symptom improvement, biomarker reduction, or
disease activity scores at 8–24 weeks.
That’s long enough to show the drug works.
But not long enough to show that it keeps working.
Immunogenicity—especially the development of ADAs is
usually tracked, but rarely treated as a critical outcome.
There is no standardized threshold for concern. No mandate
to demonstrate long-term immune neutrality. No
requirement to show that a biologic will remain effective
after the trial ends.
That must change.
Future regulatory frameworks should:
• Require longitudinal ADA tracking through at
least 12–24 months
• Define clinically meaningful thresholds for
immunogenicity-related efficacy loss
• Encourage adaptive trial designs that include
durability endpoints like drug survival, time-to-
switch, or immune quiescence
• Incentivize immune-compatible delivery routes
(e.g., oral, mucosal) and tolerogenic formulations
with expedited review or data exclusivity extensions
This isn’t about slowing approvals. It’s about protecting
patients and payers from early failure disguised as early
success.
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