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Chapter 2: How We Got Here

The story of biologics is usually told as a triumph. And in
many ways, it is. We unlocked the tools of molecular
biology, taught cells to produce medicine, and delivered
therapies that could do what small molecules never could.
Diseases that once had no options—like Crohn’s,
rheumatoid arthritis, multiple sclerosis, and dozens of rare
conditions—suddenly had answers.

But if you zoom out, another story emerges—one that’s
harder to market but essential to understand.

For all their sophistication, biologics were born into a
system that was optimized for launch, not longevity.
They were designed to meet a regulatory standard, to clear
a clinical trial, to generate return on investment. They were
not designed to teach the immune system to accept them.
That was never part of the contract. And over time, this
omission—this failure to prioritize immune compatibility—
was quietly absorbed into every level of the system.

It didn’t happen all at once. It happened gradually,
incrementally, AND invisibly.

Researchers focused on efficacy, not tolerance. Regulators
looked for short-term safety, not long-term resilience.
Clinicians followed treatment algorithms that rewarded
switching, not understanding. And pharmaceutical
companies invested where the incentives were clearest: in
launch timelines, reimbursement strategies, and next-
generation molecules that often looked suspiciously like the
last.

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