thanks for the info clark - and agree with your points regarding MW, etc., and agree it does seem passing biologics/immuno is harder than the check mark from OGD, so i am still very much hopefull mnta retains sole generic for some time to come. i guess what i found disappointing (and surprising) when i learned amphastar met the 5 criteria years ago is that wheeler was asked at the Q2 cc if based on techniques in the literature* one can meet the criteria and he said NO flat out - that one would have to develop unique tools. so meeting the 5 criteria is a wall that i thought would stand for some time
now it can be that the 5 criteria have evolved to be more stringent as you suggest since 2004/5, and neither applicant today can meet the criteria - who knows (it is still curious that teva stated they met "chemical sameness" - why not state they met the 5 criteria??)
*edit: all of the tools amphastar used in the link you provide are well knows ways to characterize sugars
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