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reviews—before earning the right to be prescribed. This
process is often framed as the gold standard for ensuring
safety and efficacy. And in many ways, it is. But like every
system, it’s defined by what it prioritizes—and what it’s
willing to overlook to get a drug to market.

And what it has consistently overlooked is immune
durability.

In theory, the regulatory model—especially in the U.S.
(FDA) and Europe (EMA)—is built to protect patients.
Drugs must demonstrate safety and effectiveness, typically
across a Phase I–III clinical trial framework. But in
practice, the bar is set for early success, not long-term
compatibility. Efficacy is typically evaluated at 12 to 24
weeks. Safety monitoring may extend a little longer. But
immune rejection—something that often emerges after a
year or more of exposure—rarely factors into the decision
to approve a drug.

Yes, immunogenicity data is collected. Yes, anti-drug
antibody (ADA) formation is measured in some trials. But
there are no universal thresholds for concern. No
mandatory long-term follow-up. No regulatory trigger that
halts or delays approval based solely on signs of
tolerization. If the drug shows short-term benefit, it’s often
deemed “effective,” even if a significant percentage of
patients may lose response after just a year.

Why this short-term bias? The answer is structural.

Regulators face immense pressure:

• From patients waiting for better treatments.

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