Biotech Values

[jb_118]

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



This third point is funny in that (as I recall) the specific point of the SNY lawsuit against the FDA with respect to mEnox is that the in-vivo immunogenicity data was used by the FDA to show safety, which is against statue. FDA didn't dispute that would be against statue, but just stated they didn't use that data for safety/efficacy, but rather manufacturing purity. In this light, the SNY lawsuit might turn out to be more about keeping TEVA from getting approval than getting mEnox revoked.

TEVA could pull branded lovenox right off the shelf and not get it approved as a generic unless they are able to prove it is the same drug by some means other than in vivo testing. There are two hurdles here. 1) come up with a sufficiently similar drug; 2) show it is the sufficiently the same by means allowable by statue (i.e the same mix of molecules, not just similar efficacy which can't be an approval consideration in the ANDA mechanism).

At this point i'm not sure they've done either one.