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1.2 – What Is Tolerization?

Tolerization is not a formal diagnosis. You won’t find it as
a billing code or hear it during a press conference
announcing the approval of a new biologic. But for millions
of patients, it’s the turning point—the moment when a
revolutionary drug becomes just another failed promise.

Unsurprisingly, the word tolerization is rarely used—by
physicians, by pharmaceutical companies, or by regulators.
It doesn’t appear on drug labels. It’s not coded into
insurance reimbursement systems. It’s absent from glossy
marketing brochures and clinical trial highlight reels. And
yet, its absence from the official vocabulary only
underscores how deeply inconvenient the concept is.

To name it would be to confront it—to admit that our most
advanced therapies, often marketed as lifelong solutions,
have a fundamental flaw that can’t be ignored or easily
fixed. By avoiding the word, the system avoids
accountability. But for patients, the experience is real,
recurring, and devastating—whether or not it has a name.

Tolerization, in the context of biologic medicine, refers to
the immune system’s gradual recognition and rejection
of a biologic drug. It's defined in simple terms by the
National Cancer Institute as,

“A process that involves the human immune system
learning from experience and remembering what it learns.
Occurs when the body gets used to a medicine so that either
more medicine is needed or different medicine is required.”

Technically, this is often called immunogenicity, but
tolerization more accurately captures the patient

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