Page 347 - Binder2

divided along rigid franchise lines—autoimmunity,
oncology, endocrinology—with each group responsible for
managing and expanding its own product portfolio. Their
objectives are clear, but narrow:

● Extend patent life through formulation tweaks or
new dosing regimens.
● Launch combination therapies that bundle old
drugs into new SKUs.
● Pursue line extensions in adjacent indications to
maximize market penetration.
● Develop companion devices (like autoinjectors or
wearable pumps) to reinforce brand identity and
delay biosimilar erosion.

In short, the mandate is not to reinvent the wheel—it’s to
polish it, rebrand it, and file a new patent.

Edible Biologics Don’t Fit That Playbook

Bringing an edible biologic into development is not an
incremental step. It’s a paradigm shift:

● It requires navigating a regulatory gray zone,
where oral delivery of unpurified proteins in plant
tissue has no clear precedent.
● It requires rethinking quality systems,
manufacturing workflows, and clinical trial designs.
● It threatens to undercut the pricing logic that
justifies injectable biologics—jeopardizing flagship
franchises that generate billions in annual revenue.
● It introduces a new delivery format that may not
align with existing salesforce models,

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