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biomaven0

08/15/10 8:00 PM

#101700 RE: bladerunner1717 #101699

I'm not sure I've ever seen a generic copy that is not substitutable. There are some non-substitutable generics that are slightly different chemical entities than the original drug - a good example is Sanofi's clopidogrel - there the first approved generics were different salts - for example, bisulfate vs. besylate.

There is even this quote by the FDA's Woodward in Congressional testimony:

Ms. WOODCOCK. Yes. We have scientific basis for our decisions on
bio-equivalence and substitutability. And we would not approve a
generic drug that was not fully substitutable for the innovator
drugs.



Peter