Biotech Values

[dewophile]

re tenox non-AB rated generic

I really see no basis for an approval on a not fully-substitutable basis. The FDA by doing this would be saying "it's sort-of the same" and if they do that they have no real basis for claiming equivalent safety and efficacy. There is no comparable situation where they have ever done this before - I believe the existing non-AB generics were all designed to be different than the originals in some way (dosage form, PK, etc.).

The issue arose when bill marth on a cc started talking about labeling talks with the FDA for enox, which makes no sense for a fully substitutable generic. now that i know bill marth talks alot of smack i think the fact TEVA was in labeling discussions was also BS so i agree it's unlikely the FDA would approve TEVA's enox as non-fully substitutable. the only thing i still can't fully reconcile is this passage in TEVA's response to SNY's petition:

"Aventis uses an assortment of theoretical suppositions and in vitro data in support of their contention that generic enoxaparin products might exhibit different pharmacodynamic profiles, anti-inflammatory effects, inhibition of smooth muscle cell proliferation, and stimulation of angiogenesis. Teva agrees that ANDA applicants for generic enoxaparin sodium injection should perform a comparative pharmacodynamic study vs. the reference listed drug Lovenox®. It is Teva’s intention to submit the PD study results for Agency review as part of our pending ANDA for enoxaparin sodium injection."

unless they were referring to in vitro testing, we know PD studies cannot be used to support a non-AB rated generic