tag:blogger.com,1999:blog-36634196.post807323003337652549..comments2023-10-09T11:33:37.853-05:00Comments on The IN VIVO Blog: Are These Large-Molecule Twins Identical? The Biosimilars ParadoxChris Morrisonhttp://www.blogger.com/profile/04075266444951558159noreply@blogger.comBlogger2125tag:blogger.com,1999:blog-36634196.post-45178178785701289472007-08-15T12:43:00.000-05:002007-08-15T12:43:00.000-05:00"But already, issues like manufacturing and the tr..."But already, issues like manufacturing and the trial requirements make biosimilars a very different economic prospect to small molecules. (Genzyme’s issues with Myozyme, outlined in this WSJ piece, illustrate how even the innovators can’t always get manufacturing right.)"<BR/><BR/>I don't think it's necessarily the innovators like Genzyme who can't get manufacturing right. The FDA puts a significant amount of pressure on them to make things perfect, when in actuality companies like Genzyme are simply just trying to provide patients with the treatment they need when they need it. <BR/><BR/>If you look at <A HREF="http://www.genzyme.com/components/highlights/WSJ_DM8_09.pdf/" REL="nofollow">this</A> letter to the editor that was published in today's WSJ, you will see that regardless of the process for producing biologic treatment, Genzyme is still providing therapy for patients free of charge. To me that says a lot about their commitment to their patients.Scotthttps://www.blogger.com/profile/16219374099462293358noreply@blogger.comtag:blogger.com,1999:blog-36634196.post-91975243471333574202007-08-10T19:13:00.000-05:002007-08-10T19:13:00.000-05:00I am not sure if hGH is the killer biological to b...I am not sure if hGH is the killer biological to begin with if you are looking to see what biogenerics will do in the market place. Interferon, eryhtropoetin, insulin are much more important drugs financially and more widely used. Recent clinical data suggests moderate effects of hGH overall. Omnitrope was IMHO a test ballon to see how the biosimilars regiment works and get the kinks sorted. The real case is erythropoeitin which is why Amgen is making such a big stink about biosimilars/biogenerics.<BR/><BR/>Also, one has to be careful to extrapolate market data from the US to Europe and vice versa. The spread between generic and origianl is bigger in the US than in Europe and the prescribing behavior is entirely different. So it does not matter if the drug is approved in both areas.<BR/><BR/>Finally, the SF Chronicle pointed out today that lifting of patents does actually enhance competition and innovation (there is a plethora of studies out there on that). Isn't that what biotech's are supposed to be about, being smarter and better? So why advocate protectionism and status-quo, Amgen ? That is a paradox indeed.Anonymousnoreply@blogger.com