I doubt very much if clinical trials will be required for generic copaxone. Think about it, either it is the "same" or it is not. How are you going to test if it is the same, run a clinical trial and see if the results replicate copaxone? That won't work.
As for safety, sure they can run clinical trials for safety, but sugar water is safe. A copaxone that is not the "same" can also be safe. It it is the same, then it is equally as safe and equally as effective (calling copaxone "effective" is somewhat of a stretch as sometimes I think a placebo would be more cost-effective, but give it its due, it sells $2 billion per year).
As MNTA identified with lovenox, multiple criteria that demonstrably showed "sameness" and in fact identicalness. MNTA will most likely be doing the same for copaxone. The factors may not be identical to that by lovenox, but I believe the protocols will be similar, with each specific element tailored towards copaxone.
Given the way that Teva is behaving (and we had this discussion on MNTA and Teva lovenox earlier today) Teva is panicked that the FDA is going to approve MNTA's copaxone application. They have good reason to be.
No, clinical trials do not seem likely, or in fact anything helpful at all given the legal process involved. Past complex generics that no one gained approval on have not required clinical trials either. It is what Teva is demanding however, which is the only reason I brought it up.
My concern is primarily with the on-going litigation. A loss there would be devastating. There is also the FDA risk, but I think that less than the litigation risk. Having to wait until 2014/2015 to launch mCopaxone would be devastating. Who the heck knows what the MS market will be in 2015. The value of a sole generic may be much less by then, and I don't like to wait 3-4 years for a fruition point.
But that is more the focus of my concern, and perhaps it is overblown. We will find a lot out when the Markman ruling is made that defines the patents at issue in regard to what the jury is to consider.
Tinker
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