[vedtopkar]

This is cool, but what they're claiming is puzzling. Perhaps someone here can clarify.

Making generic drugs is non-trivial. The medicinal chemistry may be decades old, but you still need to do trials to demonstrate efficacy equivalency to the non-generic version. Are they really saying they'll do 100 of these trials by the end of the year?

While this is cool, I'm thinking that this type of initiative should be done by the federal government. A generic drug "mint" if you will.

[s1artibartfast]

This is not accurate. Generics in the US skip animal testing, clinical trials, and bioavailability testing.

https://www.fda.gov/drugs/types-applications/abbreviated-new...

https://www.fda.gov/consumers/consumer-updates/generic-drugs....

[vedtopkar]

Sure, but I never said anything about clinical trials? Just bioequivalence, which is exactly what’s stated in your first link.

[enchiridion]

Why does this generic have to be retested if it's the same as the existing generic? Can't they just do composition(?) testing to very it meets manufacturing standards?

[vedtopkar]

I don’t have the best answer for you, but there are a number of considerations apart from the synthesis of the active molecule itself. Delivery vehicle can alter the physiological impact of the active substantially, and so the overall “package” needs to be tested even though the active is already approved.

To my knowledge, generic trials aren’t as involved as their non-generic counterparts for obvious reasons. But they are still non-trivial logistical undertakings.

[enchiridion]

That makes sense! This is where I feel like I have a disconnect between what I think applied science is and what it looks like in practice. It seems like they should know enough about the molecule, delivery vehicle, etc, to know that it will work the same. A medical "proof" if you will. I guess we're not quite there yet? Is there work pushing in this direction?

[vedtopkar]

Sadly I don't know enough to give you a good answer. But I'm certain there are smart people working on it!

[s1artibartfast]

They don't. Please see my sibling comment

[CapriciousCptl]

You're right. If it was just one drug, I'd think they were manufacturing it themselves. Apparently, they plan to have a single factory in 2022. Most likely, significantly all of their formulary will be copacked.