Biotech Values

[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