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The Question We Must Ask

If a biologic cannot persist in the face of immune scrutiny,
was it ever designed for the long haul? Or was it built for
initial efficacy and market success—durability be
damned?

This book argues that unless we address tolerization head-
on—immunologically, technologically, and
commercially—we are building a future of medicine that
cannot sustain itself.

Because when the body says no to a $300,000 drug, it’s not
just a biological response.
It’s a referendum on the system that delivered it. It’s our
bodies telling us we’re trying to fit a square peg into a
circle hole.

The answer isn’t going to battle against our own cells. It's
collaboration.

1.3 – How Common Is It? (More

Than You Think)

Depending on the biologic, 10% to 30% of patients may
experience a loss of efficacy due to immunogenicity—
sometimes within months of starting treatment.

• In hemophilia A, up to 30% of patients develop
inhibitors to Factor VIII.
• In rheumatoid arthritis, patients taking anti-TNF
drugs like Humira or Remicade often rotate

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