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• Are safety and efficacy endpoints the same for
tolerizing therapies as for suppressive ones?

To answer these, regulatory bodies are beginning to
adapt—but slowly.

Early Precedents and Hybrid Models

Some early programs have found traction by building
hybrid regulatory strategies:

• Purified protein pathway – In some cases, the
protein is partially extracted from the plant and
delivered in a standardized capsule, making it easier
to classify under traditional biologic pathways (e.g.
BLA submission).
• Orphan or Fast Track status – For rare diseases
and pediatric applications, the FDA has shown
flexibility in allowing novel production methods if
preclinical data is strong and the clinical need is
urgent.
• Plant-made pharmaceutical precedent – A few
plant-produced biologics (like ZMapp for Ebola or
taliglucerase alfa for Gaucher’s) have already
moved through regulatory review, paving the way
for others.
• Combination product frameworks – In cases
where the plant acts as both production system and
delivery vehicle, some programs may be evaluated
as combination products (drug + device analogues).

Still, most regulators expect rigorous demonstration of
identity, consistency, safety, and immunologic effect—
even when the route of delivery is novel.

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