Biotech Values

[jq1234]

What do you make of the fact that the FDA argument here rests solely on the lack of a good and stable raw material supplier - not one word in there about lack of "sameness" or failure to meet their 5 criteria?

Here are the answers on page 14:

D. Amphastar relied upon a defunct heparin supplier in generating its data
regarding active ingredient “sameness” and impurities.

Because heparin from different manufacturers is not necessarily equivalent, and can differ
in key quality attributes, AR 464, FDA concluded that the data that Amphastar had submitted to
demonstrate “sameness” as to enoxaparin made from heparin supplied by KY, could not be
presumed to support a conclusion of “sameness” as to enoxaparin made from heparin supplied by
QJBC. AR 464-65. Differences in the quality of crude heparin used to produce heparin, or in
manufacturing and purification processes, could be material. AR 464. For the same reasons, FDA concluded that the data that Amphastar had submitted regarding impurities were
incomplete, because heparin from different suppliers could have different impurity profiles. AR
464-65.

In December 2008, FDA informed Amphastar that the ANDA was not approvable for
lack of complete data regarding active ingredient sameness and impurities.

Thus, there is no point to argue whether they actually achieved "sameness" when the data generated considered invalid.