Biotech Values

[RockRat]

RE: m-Copaxone bioequivalence trial:

>>ANDAs for injected drugs ordinarily don’t need bioequivalence studies because such drugs, by definition, don’t have the variability in bioavailability that comes from variability of dissolution in the GI tract. However, it’s conceivable that the FDA may nevertheless want a bioequivalence study for NVS/MNTA’s generic Copaxone. If there is any chance of this, it would make sense for NVS/MNTA to conduct such a study prophylactically rather than getting hit with a deficiency letter later.<<

Given the following (from a Teva PR, but no reason to doubt accuracy in this instance):

"Moreover, once subcutaneously injected, it is rapidly hydrolyzed locally and no level of the intact drug can be measured in the blood, rendering a bioequivalence study comparing two formulations extremely difficult."

How do MNTA/Sandoz get around this?

I know this has been mentioned before, and my recollection is no one had a satisfactory answer.

Regards, RockRat