http://www.patentbaristas.com/archives/2007/03/26/fda-chief-biogenerics-will-be-similar-not-interchangeable/?utm_source=rss&utm_medium=rss&utm_campaign=fda-chief-biogenerics-will-be-similar-not-interchangeable Freshly Brewed Bio/Pharma Chat. Served Up Daily. Tue, 07 Feb 2012 11:57:58 +0000 hourly 1 http://wordpress.org/?v=3.3.1 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. [...]

]]>