Replies to post #92991 on Biotech Values

[DewDiligence]

Your Copaxone post is spot-on and crystallizes what I was driving at in my reply to Peter in #msg-48120081:

Notwithstanding the copious disclosures in the Copaxone patents, one presumably needs MNTA’s informatics tools—or some equally powerful toolset—to convert this knowledge into a full-fledged, commercial process.

Together with the disclosures in the Copaxone process patents, MNTA’s proprietary informatics tools allow MNTA to specify the batch-to-batch tolerances of branded Copaxone and thereby ensure that every batch of the generic product falls within these tolerances. Exactly as you stated.

[genisi]

Of course MNTA looked at many batches of Copaxone to ensure their version is not too different (between and within batches of their own product and of reference standards - the branded), I don't believe they would have submitted an ANDA without that. However, they cannot show pharmacokinetic properties (no detectable serum levels, no activity test, no biomarker, no proven MoA), and prove their product is as safe and active. Showing sameness with biochemical analytical lab tools won't be enough to satisfy the FDA in this case, they need to show bioequivalence and this will require clinical studies, imo.