No, the one I posted two pages ago, which you keep ignoring.
Here you go, crazy person.
In perhaps the least surprising thing to ever happen, this (
#20,663) was completely correct. Except the workaround wasn’t buried it was directly in the statute referenced in the biologics license.
Section 42 USC 262 allows the FDA to approve biosimilar, interchangeable products under the auspices of a pre-existing approval for a reference product.
Here’s 42 USC 262(i)(4), specifically, note the definition of a “reference product.”
42 U.S. Code § 262 - Regulation of biological products
(4) The term “
reference product” means the single
biological product licensed under subsection (a) against which a
biological product is evaluated in an application submitted under subsection (k).
Subsection (a) is the biologics license application process under which FDA approval is given. That is the same section used by Pfizer and the FDA to approve Comirnaty. See: approval of Pfizer Biologics License Application (BLA) linked below, and note that “Section 351(a) of the Public Health Service Act” is the same 42 USC 262 linked above. If you have doubts about that, you can confirm it with a Google search.
https://www.fda.gov/media/154939/download
So, since there is an approved biologics license for “Comirnaty,” granted pursuant to Section 351(a), it is a “reference product” as defined in 42 USC 262.
Now see the definition of interchangeable from 42 USC 262(i)(3).
(3) The term “interchangeable” or “interchangeability”, in reference to a
biological product that is shown to meet the standards described in subsection (k)(4), means that the
biological product may be substituted for the
reference product without the intervention of the health care provider who prescribed the
reference product.
Subsection (k) describes an abbreviated application and approval process involving comparison of biosimilars to a reference product. Basically, if the product meets the criteria for “biosimilar,” then it can be grandfathered in.
Here it is Explained by the US Court of Appeals for the Federal Circuit:
Amgen Inc. v. Sandoz, Inc., 794 F. 3d 1347 - Court of Appeals, Federal Circuit 2015 - Google Scholar
It’s not clear that Pfizer applied under this subsection, but I also can’t find their application under subsection (a), and it makes sense that those would contain protected information. Regardless, the FDA has given guidance to caregivers saying that the two are interchangeable. (See footnote 1 here:
https://www.fda.gov/media/155234/download, and also several places here:
https://www.fda.gov/media/153716/download).
I assume the old name is retained on the labeling because this makes the drugs more versatile given that there are still some EUA only uses.
Also worth noting that the approval posture for Moderna’s spikevax brand seems the exact same.
This post is not legal advice. As always, hire a lawyer. (You’re gonna need one because, from now on, you can’t argue with me, I’m an attorney.)[/quote]