Husband works in pharma (on drug launches) and obviously understands how approvals work. He said that there have been a handful of instances of approval of “bio-similar” drugs— which basically just means that the original drug has been used for so long and is so safe that the FDA will approve a drug that is essentially the same because additional studies probably wouldn’t add any valuable information (think something like NSAIDS, they all work exactly the same way and carry the same risks).
He said that this approval looks like they are trying to pull off something representing a bio-similar approval in a manner that is obviously blatantly against their own rules. Basically it’s complete bullshit.
Oh and apparently those 2 FDA vaccine people who quit is actually a really big deal and notification is going around to pharma people. Idk if that means anything but I found it interesting.
Husband works in pharma (on drug launches) and obviously understands how approvals work. He said that there have been a handful of instances of approval of “bio-similar” drugs— which basically just means that the original drug has been used for so long and is so safe that the FDA will approve a drug that is essentially the same because additional studies probably wouldn’t add any valuable information (think something like NSAIDS, they all work exactly the same way and carry the same risks). He said that this approval looks like they are trying to pull off something representing a bio-similar approval in a manner that is obviously blatantly against their own rules. Basically it’s complete bullshit. Oh and apparently those 2 FDA vaccine people who quit is actually a really big deal and notification is going around to pharma people. Idk if that means anything but I found it interesting.