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Re: AlpineBV_Miller post# 50635

Monday, 08/06/2007 11:49:57 AM

Monday, August 06, 2007 11:49:57 AM

Post# of 257425
BSR David, Just wondering if you could elaborate on your rationale for saying that biogenerics is a fad?

One big potential problem for the biogeneric concept is that reproducing an identical copy of these large complex molecules may not be possible. If the molecules aren't exactly the same, their efficacy and side effect profiles could be vastly different than the original. To ensure equivalence would involve expensive large scale clinical trials by the generic company. Has the need for these trials been fully addressed in the current biogeneric legislation? Thanks for any insights.



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