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• Immune compatibility premiums: drugs designed
to engage tolerogenic pathways (e.g., oral delivery,
low-ADA platforms) receive favorable pricing
models

This would signal to developers that durability isn’t a
bonus—it’s a commercial advantage.

3. Accelerated Pathways Must Account for Long-
Term Risk

Fast-track and accelerated approval pathways have been
critical in bringing novel biologics to market—especially in
areas of high unmet need like oncology, autoimmune
disease, and rare conditions.

But speed has a cost.

Accelerated programs often rely on surrogate endpoints
and shorter trials. That means immunogenicity and long-
term durability data are either weak or nonexistent at
launch. Once approved, there’s little incentive to gather
those data meaningfully—especially if the drug is
generating revenue.

To align accelerated access with long-term success,
regulatory bodies should:

• Require mandatory post-market immunogenicity
surveillance
• Enforce timely submission of real-world ADA
and loss-of-response data
• Tie continued labeling or reimbursement to ongoing
immune durability outcomes

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