http://www.patentbaristas.com/archives/2007/03/26/fda-chief-biogenerics-will-be-similar-not-interchangeable/ Freshly Brewed Bio/Pharma Chat. Served Up Daily. Thu, 18 Mar 2010 11:54:35 -0400 http://wordpress.org/?v=2.9.2 hourly 1 http://www.patentbaristas.com/archives/2007/03/26/fda-chief-biogenerics-will-be-similar-not-interchangeable/comment-page-1/#comment-5501 Generic Biologics? | worldhealthcareblog.org Tue, 10 Apr 2007 15:35:03 +0000 http://www.patentbaristas.com/archives/2007/03/26/fda-chief-biogenerics-will-be-similar-not-interchangeable/#comment-5501 [...] That’s going to be a much higher entry barrier than the standard ANDA process for small-molecule generics, which isn’t going to help bring down costs. There are a number of tricky regulatory issues as well, and in the end we’re probably going to have to settle for “biosimilar” instead of “bioequivalent”. For more details, I can recommend this recent post at PatentBaristas. [...] [...] That’s going to be a much higher entry barrier than the standard ANDA process for small-molecule generics, which isn’t going to help bring down costs. There are a number of tricky regulatory issues as well, and in the end we’re probably going to have to settle for “biosimilar” instead of “bioequivalent”. For more details, I can recommend this recent post at PatentBaristas. [...]

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