Replies to post #119215 on Biotech Values

[DewDiligence]

So what are corresponding markers in Copaxone?

There is nothing that I would characterize as corresponding to FIIa/FXa for Lovenox, but Copaxone does do things that can be measured. Peptimmune and MNTA (it says) have measured them.

If giving a person a specified dose of branded Copaxone causes assay X to change from a baseline reading in the range of [B1, B2] to a reading in the range of [A1, A2], and giving a person a specified dose of generic Copaxone causes assay X to change from a baseline reading in the range of [B1, B2] to a reading in the range of [A1, A2], then the FDA will be more confident in concluding that the generic is sufficiently similar to the brand to approve the ANDA. It is not necessary for the applicant to understand the MoA of the drug to accomplish this (although such understanding would obviously help).

[dewophile]

re Xa/IIa activity

is responsible for an important and well-established
mechanism of action that explains, in significant part, the pharmacological activity for LMWHs

this issue has been discussed on this board before if you do a search. i agree with you that biomarkers that exist for copaxone don't quite measure up to "explaining to a significant degree the pharmacological activity" of the compound, and one is going to have to put more weight on the characterization relative to lovenox. nevertheless Xa/IIa don't fully explain the activity of LMW heparins either, and the biomarkers of copaxone do have some correlation with activity and some are even used by TEVA as manufacturing controls, so it is all relative and a question of degree