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DewDiligence

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Re: oldberkeley post# 110632

Friday, 12/10/2010 1:30:54 PM

Friday, December 10, 2010 1:30:54 PM

Post# of 257251

Do you feel that some day interchangeability can be established without any clinical data?

When companies tweak the production process for a branded biologic, they usually do not have to run new clinical trials to obtain FDA approval (although they occasionally do, e.g. with GENZ’s Myozyme/Lumizyme). I think the FDA will treat FoB’s that are extremely well characterized in a similar manner to the way they treat minor production changes to branded biologics.

“The efficient-market hypothesis may be
the foremost piece of B.S. ever promulgated
in any area of human knowledge!”

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