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3.7 – Regulatory Reform and
Reimbursement Innovation
If biologics are going to evolve from short-term
interventions into long-term, immune-compatible therapies,
science alone won’t be enough.
The regulatory and reimbursement ecosystems—the
structures that determine how drugs are approved, priced,
and paid for—must evolve with them.
Because right now, those systems aren’t just lagging
behind.
They’re reinforcing the wrong incentives.
They reward speed over staying power.
Volume over value.
And clearance over continuity.
Until that changes, immune durability will remain an
optional luxury in development—not a foundational
requirement.
Here’s what has to shift.
1. Regulators Must Prioritize Immune Durability,
Not Just Initial Response
Agencies like the FDA, EMA, and PMDA have clear
mandates: ensure that new drugs are safe and effective. But
in the world of biologics, “effective” has become too
narrowly defined—often based on short-term endpoints
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