3 ms·
And in order to get that approval, you will likely need a sample of the product that you intend to demonstrate equivalence to. Good luck getting that sample fro
by usefulcat 9y ago
And in order to get that approval, you will likely need a sample of the product that you intend to demonstrate equivalence to. Good luck getting that sample from the maker of the incumbent product who has nothing to gain and much to lose if your product were to get approved.
- refurb 9y agoNot being able to get a sample to prove bioequivalence is typically very easy. There are a handful of drugs that have a REMS program whereby the manufacturer is required to restrict access. We're talking maybe a few tens of drugs. And yes, drug companies playing the game of "I'm not allowed to give you a sample" is super shady and ridiculous. Wouldn't surprise me if this gets fixed super fast.
- AstralStorm 9y agoFDA could give overriding authority to oblige manufacturers to provide a sample to the generic manufacturers for drugs older than <x>. Of course this is bad for business. Alternatively the generic manufacturer would have to run a phase 1 and 2 trial. (Skip requirement for phase 3) Expensive, but much less than full R&D.
- refurb 9y agoMy understanding is that's the plan. Right now branded drug companies say "REMS regulations mean we can't provide a drug for anyone but a patient." All the gov't has to do is say "no, if a generic company requests a sample you can provide de it without violating REMS regulations".