Replies to post #90897 on Biotech Values

[DewDiligence]

Re: The premise of the US generic-drug system

I understand from others that an ANDA generic co. need only certify that the active ingredient is the same as that present in brand version. I do not know whether my understanding is correct or whether it derives from statute or FDA rule.

Your understanding is partially correct but omits an important requirement: US generic drugs must have bioavailability in the range of [0.80,1.25] relative to their branded counterparts. Whether this bioavailability range is sufficient for identical or nearly identical safety and efficacy depends on the kind of drug in question, as discussed in #msg-46749843.

other ingredients in [a generic] formulation may well be different. That confluence of factors may or may not result in different safety or efficacy in different individuals. That is not a good way to run a health care system IMO.

The US healthcare system, which is one of the few systems in the world with fully substitutable generic drugs, has an inherent tradeoff between exactness and availability—see #msg-46885484. Regards, Dew

[bladerunner1717]

North,

I totally agree with you. My friends on generic Wellbutrin had some serious difficulties. I was able to do some research and found out that there was an "authorized generic" (I hope I'm using the right term.) from Watson Pharmaceuticals. I told them to have their respective doctors (or should I have said the pharmacies?) make sure that they got the authorized generic.

I'm surprised that we haven't heard more (and had more lawsuits) about generics that are not exact duplicates of the original. I'm also surprised that the FDA isn't more stringent about this issue.


Bladerunner

[Biopharm investor]

north40000

That is not a good way to run a health care system IMO.

Generic substitution of branded drugs saved the US health care system $734 billion in the ten year period ended in 2008 and the savings are growing annually, with 2008 savings alone being $121 billion. Most developed health care systems around the world (facing the same economic and demographic shifts as the US) are moving toward greater utilization of generics like the US system.

And while not all generics are Q & Q, to my knowledge, there's never been any serious systemic safety issues associated with relying on PK/BE studies to support approval of a generic alternative since the advent of the generic industry in the mid 80's. If a generic does not yield the desired efficacy, the patient can simply revert back to the brand.

I find it curious that anyone would willingly sacrifice the kind of cost savings to the heath care system that generic drug substitution provides. What would you propose we do to replace the savings generated by generic substitution?