Replies to post #109457 on Biotech Values

[mouton29]

<<MNTA is able to copy copaxone and characterize the entire structure. Why did FDA approve teva's copaxone if they did not know the MOA? Why should FDA carry about MOA when MNTA will copy the strucutre and deliver sameness - hence a fully substitutable generic?>>

The FDA approved Copaxone because TEVA proved efficacy with clinical trials, not via proof of MOA.

The question is, how to prove sameness. For Lovenox, the FDA establshed five criteria, the last two of these, equivalence in biological and biochemical assays and equivalence of in vivo pharmacodynamic profile, seem to me to be derived from the known MOA of Lovenox. As of the May 2010 denial of TEVA's Citizen petitio, the FDA had not decided on what to ask for to prove Copaxone sameness but their response has some hints and certainly suggests they will come up with something.

[genisi]

Why did FDA approve teva's copaxone if they did not know the MOA?

Because efficacy and safety of glatiramer acetate were demonstrated in double-blind, controlled clinical trials!

[Biowatch]

Safety and efficacy, not MoA = FDA approval.

Knowing the MoA is nice, but that often comes long after drug approval.

Even scientists well versed in their field can be surprised as to how or why something works.