tag:blogger.com,1999:blog-36634196.post1012241922990971016..comments2023-10-09T11:33:37.853-05:00Comments on The IN VIVO Blog: No GLP-1s? Never Mind, Says NovoChris Morrisonhttp://www.blogger.com/profile/04075266444951558159noreply@blogger.comBlogger2125tag:blogger.com,1999:blog-36634196.post-43537752307964365662009-04-04T04:29:00.000-05:002009-04-04T04:29:00.000-05:00i like your blog<B>i like your blog</B>♥♥♥♥♥ Jennifer™® ♥♥♥♥♥https://www.blogger.com/profile/15369583052701337325noreply@blogger.comtag:blogger.com,1999:blog-36634196.post-27940835836454416802009-04-03T12:20:00.000-05:002009-04-03T12:20:00.000-05:00Novo's confidence is admirable, but may be a bit f...Novo's confidence is admirable, but may be a bit foolish, both when it comes to Victoza and "modern insulins". The reason: Novolog/Novorapid's U.S. patent expires in 2013, a mere 4 years away, and by then, it is almost certain that follow-on versions will have an approval pathway outlined by Congress (technically, insulin is grandfathered under the Federal Food Drug and Cosmetics Act, and therefore could be subject to follow-ons today, although the FDA has been dragging its feet on issuing guidance), but an ambitious generics maker might push the issue using the 505(b)(2) pathway and the FDA might <I>have</I> to consider such an application, just as it did with Omnitrope HGH. Novo's other "modern" insulin has a few more years before subject to follow-ons, but that product, as a "me-too" to Sanofi's Lantus, isn't quite the blockbuster Novo hoped it would be, at least according to IMS sales data. Novo may be playing it cool, but we can be sure management is nervous as hell right now.Anonymousnoreply@blogger.com