Biotech Values

[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.