Page 450 - Binder2

• Biologics that require frequent switching are
systemic cost drivers, not neutral actors.
• Immune rejection is a public health inefficiency,
especially in chronic disease settings.
• The regulatory bar must reflect real-world
durability, not just trial-based response.

Still, the path forward requires courage. For regulators to
truly lead, they must:

• Define what “immune durability” means in practice.
• Incentivize tolerogenic platforms through fast-track
or breakthrough designations.
• And most critically—codify immune harmony as
an essential aspect of therapeutic success.

It won’t happen overnight. But even the hint of regulatory
movement changes industry behavior. And with
tolerization now on the table, the door is open for the next
generation of biologics to walk through it.

A Converging Momentum

Together, these forces—startups building for trust,
scientists translating tolerance into therapy, and regulators
testing new standards—represent the early architecture of a
new biologic ecosystem.

It’s not yet dominant.
But it is alive.
And accelerating.

These players aren’t waiting for the system to collapse.
They’re designing a better one. One that assumes drugs

448