Page 37 - Binder2

In other words, raising the bar for immune compatibility
would slow the system down. And in a world driven by
quarterly earnings, public health pressures, and intense
competition for innovation, speed often wins out over
sustainability.

So the compromise is made—consciously or not.
Regulators approve based on early efficacy and known
short-term risks, while post-marketing surveillance is left
to pick up the pieces. If ADA-related loss of response
occurs after a year or two, it’s not the trial’s failure—it’s
the system working “as designed.”

But here’s the catch: there is no centralized, standardized
system for tracking tolerization in the real world. ADA
testing is inconsistent. Reporting is voluntary. Long-term
follow-up studies are often underfunded or delayed. What
results is a fragmented picture—one that hides patterns,
blurs accountability, and makes it nearly impossible to
evaluate the true durability of biologics across populations.

In effect, we’ve created a regulatory framework that
ensures biologics enter the market quickly—but not
necessarily with the immune resilience needed for long-
term use. And while that may serve the needs of market
access and innovation pipelines, it leaves patients—and
payers—vulnerable to therapies that are biologically
brilliant, but immunologically brittle.

Until immune tolerance is prioritized as a core efficacy
endpoint, tolerization will continue to be treated as a post-
approval footnote.
But for the patients living through it, it’s not a footnote. It’s
the whole story.

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