Replies to post #99850 on Biotech Values

[DewDiligence]

Re: Generic Copaxone

It seems that the crucial issue for FDA approval of Copaxone is if Momenta is able to show bioequivalence (which is almost impossible according to Teva).

A few comments:

1. It’s not absolutely certain that the FDA will require generic Copaxone to show bioequivalence to the branded product.

2. NVS and MNTA think they can show bioequivalence if it is necessary to do so.

3. The FDA flat-out rejected Teva’s Citizen Petition, which alleged that it was impossible for a generic to be therapeutically equivalent to branded Copaxone.

4. Teva’s statements to date vis-à-vis generic Copaxone have included so much propaganda that it’s hard to take seriously anything that Teva says on this topic.

Regards, Dew

p.s. Welcome to the board!