Replies to post #101768 on Biotech Values

[bladerunner1717]

Thanks, rkrw.

So if I understand you correclty, given that Sandoz/MNTA filed a certain way, there was no chance that the FDA could have approved Sandoz's application without granting a "fully substitutable" designation. (If that's the case, then I don't understand why Dew made such a big deal about its being "fully substitutable," since it couldn't have been approved any other way.)

This leads me to another question. If it's the sponsor that is doing the differentiating, then why is there all this talk on this board about Teva's drug being approved as "not substitutable?" Clearly, Teva did not file "as a brand as a business strategy."

Since Wellbutrin XL by Teva did not undergo clinical trials, as far a I know, then I can assume that Wellbutrin XL was approved by the FDA as a "fully substitutable" generic. Why then is Teva's Wellbutrin XL referred to as a "branded generic?" (as opposed to just a "generic," the way that enoxaparin is referred to).

If SNY were to launch an "authorized generic," under what brand name would it be marketed? (I'm assuming that SNY would continue to sell its branded original under the SNY label.)

Thanks again.

Bladerunner

[DewDiligence]

It's not the FDA that differentiates, it's the sponsor. They intentionally file as a brand as a business strategy.

It’s not always the sponsor’s intent to have a non-substitutable product. Duramed’s Cenestin, which was the subject of a recent thread on this board, is a case in point. The FDA rejected the ANDA and told Duramed to resubmit under 505b2.