Replies to post #93007 on Biotech Values

[rkrw]

If someone can point out a time Genisi has been wrong on this board, please point it out :)

[DFRAI]

OT - MNTA - copaxone (genisi, dewdiligence)

wouldn't mnta/novartis know this? shouldn't they interact with fda to find out by now what they would need to submit as part of complete package?

it would be very foolish of them or anyone else to just wait around for the lawyers without undertaking in parallel these efforts if they want to be successful in getting approval.

[dewophile]

they cannot show pharmacokinetic properties

yes - i never disagreed with this point. whether this will make the difference between approvability or not is the question

after all you can't asses pk of lovenox in the traditional sense of measuring drug levels either - you need to indirectly check pk by measuring anti-Xa levels. so yes the big difference between lovenox and copaxone is there is no biomarker of activity that can be used for pk/pd - but i would also argue if approving generic lovenox requires simply showing one can achieve comparable inhibition of Xa/IIa activity then we will see multiple generics approved. However, if the FDA feels that Xa/IIa activity cannot fully descrive the activity of lovenox, and they approve an ANDA based on technology such as MNTA's, then i would argue having Xa/IIa as a biomarker is not the key to proving sameness - rather the technology and reverse engineering and showing similar batch to batch consistency of the final product mix is what is necessary, and having the luxury of a biomarker that gives some indication of activity of the final product then becomes merely supportive of the application

[DewDiligence]

Re: Approval requirements for generic Copaxone

Idit, did you notice that the FDA requested—and NVS/MNTA already submitted—data on Copaxone gene expression? This tidbit was in the legal pleadings by the FDA (technically, the HHS Dept.) in Teva’s recent lawsuit against the FDA (HHS) that was dismissed by the Court (#msg-101929561, #msg-101928012).

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.

Given the language in the FDA’s pleadings in the same case, I think we can now rule this out—see #msg-101928410. Regards, Dew