>>Teva’s written response to SNY’s Lovenox Citizen Petition indicates that Teva wants the FDA to define sameness as the same degree of inhibition of Factor Xa and Factor IIa as in branded Lovenox.
Given a mixture with many highly active components, TEVA's position is laughable. Sure if you get Xa and IIa right it should work on those targets. But there is no way without studies to know what other effects that are different may have been introduced.
MNTA is right about sameness. It either is the same and should be substitutable or it is not and you need studies. It is economically self-defeating to require studies when the purpose of creating generics is to introduce price competition without lessening the therapeutic benefits.
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