3 ms·

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 deca

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.

CapriciousCptl 6y ago
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.
enchiridion 6y ago
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 6y ago
  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 6y ago
    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 6y ago
      Sadly I don't know enough to give you a good answer. But I'm certain there are smart people working on it!
- s1artibartfast 6y ago
  They don't. Please see my sibling comment
s1artibartfast 6y ago
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-drug-application-anda https://www.fda.gov/drugs/types-applications/abbreviated-new... https://www.fda.gov/consumers/consumer-updates/generic-drugs-undergo-rigorous-fda-scrutiny#:~:text=Today%2C%20more%20than%208%20in,States%20are%20for%20generic%20drugs.&text=Because%20generic%20drug%20makers%20are,expensive%20than%20brand%2Dname%20drugs https://www.fda.gov/consumers/consumer-updates/generic-drugs....
- vedtopkar 6y ago
  Sure, but I never said anything about clinical trials? Just bioequivalence, which is exactly what’s stated in your first link.

CapriciousCptl 6y ago

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.

enchiridion 6y ago

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 6y ago
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 6y ago
  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 6y ago
    Sadly I don't know enough to give you a good answer. But I'm certain there are smart people working on it!
s1artibartfast 6y ago
They don't. Please see my sibling comment

s1artibartfast 6y ago

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-drug-application-anda https://www.fda.gov/drugs/types-applications/abbreviated-new... https://www.fda.gov/consumers/consumer-updates/generic-drugs-undergo-rigorous-fda-scrutiny#:~:text=Today%2C%20more%20than%208%20in,States%20are%20for%20generic%20drugs.&text=Because%20generic%20drug%20makers%20are,expensive%20than%20brand%2Dname%20drugs https://www.fda.gov/consumers/consumer-updates/generic-drugs....

vedtopkar 6y ago
Sure, but I never said anything about clinical trials? Just bioequivalence, which is exactly what’s stated in your first link.