Replies to post #111680 on Biotech Values

[DewDiligence]

Nowhere does the FDA say that meeting the five criteria for Lovenox sameness is sufficient for FDA approval of generic Lovenox. Rather, the FDA says that the five criteria are “to be used” in the review of a generic-Lovenox application, which I interpret to mean as necessary but not sufficient for FDA approval. Hence, I respectfully disagree with the inferences you are drawing in this thread about how close (or distant) to FDA approval Teva and Amphastar are likely to be.

[HattieTheWitch]

assessing the "junk", at least for regulatory purposes, is gauged by immunogenicity...

I see the additional tests you reference which the FDA required - are these the ways one tests for immunogenicity?

[iwfal]

MNTA - random historical background data on 'sameness' and 'impurities' and 'immunogenicity':

Citizen's Petition data on Amphastar product:

http://www.fda.gov/ohrms/DOCKETS/dailys/04/June04/060804/03p-0064-c00002-vol3.pdf

The interesting (to me) items include: 1) the wide variance allowed for molecular weight and 2) the number of peaks in the amphastar data (aka impurities) that just don't exist in the Lovenox data.


Momenta's view of FDA's interim assessments given by the FDA to applicants:

http://investorshub.advfn.com/boards/read_msg.aspx?message_id=56244828

And then a final comment on all of this is that as a result of this latest flare up it appears that for many years the roadblock to approval of a generic enox has been the biologics area (currently in the form of immungenicity) - and OGD (about 'sameness') has always been the easy grader. And as TEVA has acknowledged their review is now in with biologics division.

Interesting question - how much did the "how" part of sameness (the bulk of the 40 pages describing the sameness criteria) evolve over time from 2004/5 as the biologics division provided feedback.

[DewDiligence]

…since levels of [heparin-PF4 complex] antibodies are felt to be linked to heparin induced thrombocytopenia, i don't think the FDA will allow any flexibility on this issue.

FDA leniency on this score is unlikely insofar as antibodies to heparin-PF4 complex are associated not only with HIT per se, but also with a poor survival prognosis in such Lovenox indications as orthopedic surgery and ACS.