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This Is Not Red Tape—It’s Realignment

These changes aren’t bureaucratic hurdles. They’re
structural updates to reflect biological reality.

Because the immune system doesn’t care about PDUFA
dates.
It doesn’t care what’s on the formulary.
It doesn’t care what the label says at Week 12.

It cares about what it sees, how it’s introduced, and how
often it’s challenged.

If the systems around biologics fail to reflect that
complexity, we will continue to launch drugs that are built
to fail—slowly, silently, and expensively.

But if we realign regulation and reimbursement with
immune reality, we unlock a different future:

• One where therapies last
• One where biologics earn trust
• One where immune compatibility becomes a
competitive edge, not an afterthought

Because biologics weren’t built to be disposable.
And the systems that approve and pay for them shouldn’t
treat them that way.

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