Biotech Values

[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.