>>But what if phase II studies will not be required at all, or like in Omnitrope's case which was approved after full phase III but no phase II dose ranging and less tox data.
IF a proposed dupe of a biologic has not been comprehensively examined for "sameness" then why would FDA allow the company to skip any of the studies including animal and tox? And if they can't skip studies then the company might as well present as a new biologic.
IF a biologic is believed to be the same as a branded biologic, wouldn't it be difficult to prove sameness in a study? Seems that you could not prove sameness without a large study and with a high-powered study there would be a greater likelihood of showing that the dupe is different.
Given FDA's conservative tendencies, over time it seems possible that they would require very expensive and time consuming studies that would defeat the societal gain we hope for from FoB's.
Given these tradeoffs it suggests to me that society would be better off setting drug prices after patent expiration. It would save all the huge wasteful expense and administrative non-sense to produce something we already have from one company. Wow - did I just say that?
:-)
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