Replies to post #2148 on Teva Pharmaceutical Industries Ltd (TEVA)

[DewDiligence]

Re: Will Copaxone will regulated as a biologic?

I don't believe the FDA will treat this other than a biologic drug - meaning full clinical trials to demonstrate safety and efficacy will be required.

The key word in your post is full, and this is where I respectfully disagree.

I concur that some clinical testing for generic Copaxone is likely, but I highly doubt that it will need to be a full clinical program that starts from square one and is unable to rely in part on the branded Copaxone dossier.

If what you assert were what the FDA actually wanted, the FDA would very clearly not have accepted the Copaxone ANDA for review—they would instead have requested that the sponsors submit a regular NDA.