Replies to post #107417 on Biotech Values

[tinkershaw]

Here is Teva's comment after MNTA's approval:

After reviewing the FDA's response to the citizen petition, which outlines 5 criteria to demonstrate "sameness", Teva believes that it has demonstrated to the FDA that its version of generic Lovenox meets their criteria and that Teva's pending ANDA is approvable.

Teva maintains the approval for an ANDA for generic Lovenox is appropriate because:
- The active ingredient in enoxaparin is significantly better characterized than the active ingredients of significantly more complex molecules
- Pharmacologically active portions of enoxaparin can be identified and replicated, and
- In vitro and in vivo PD tests are rapidly indicative of drug efficacy and safety

Reading it in context of this Indian drug, yes, Teva was exactly accurate. The drug has the pharmacologically active portions of enoxaparin, and in vitro it acts in the same manner in efficacy and safety as lovenox because it is a form of LMHW, as is lovenox, just like the other branded variants of LMWH, none of which qualify as directly substitutable to lovenox. Also, yes, lovenox is better characterized than more complex molecules. And the moon is better mapped and understood than is the surface of Pluto. But at this time, Teva, sorry, I don't think copaxone is any less characterized than lovenox at this point.

However, nothing in that statement is indicative of meeting the standards that the FDA laid out. NOTHING. It is all just a manner of expressing that we have submitted a LMHW substance that acts similarly to lovenox, just like any other branded LMHW would.

This is all making more and more sense when viewed in context.

Tinker