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And now, as patients cycle faster, costs rise higher, and
payers grow more skeptical, that omission is no longer
hidden. It’s becoming the defining challenge of modern
biologic medicine.
The question is no longer: Can we make a biologic that
works?
We can.
The question is: Can we make one that stays?
2.8 – Why the System Didn’t Change
By now, the question is obvious
If tolerization is so common, so costly, and so
preventable—why hasn’t the system changed?
The answer is deceptively simple: because no one was
forced to change it.
In medicine, as in most industries, problems don’t get
solved just because they exist. They get solved when they
threaten something that matters to the system—
regulatory credibility, investor confidence, patient safety
headlines, or reimbursement models. Tolerization, for all its
downstream damage, never triggered those alarms.
Why?
Because it was interpreted as manageable.
Loss of response could be explained away: maybe the
patient missed doses. Maybe the disease progressed. Maybe
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