"You take that biologic you originally had, you change the structure, [and] you get a new product."
Hate to rain on your parade, but altering the device which
delivers the biologic is not the same as altering the
structure of the Biologic itself.
If you think that putting the same drug into a Unifill
device will extend the patent life of a biologic by another
12 years then I believe you have misunderstood the
purpose of this new legislation.
A change in the Biologic itself that improves safety, eg.
less side-effects, is grounds for applying for a new or
supplemental DLA, but I can't see the FDA granting one
just because the delivery mechanism has changed.
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