http://www.biotechblog.com/2007/03/27/the-commercial-prospects-of-biogenerics-how-much-will-they-save/ Commercial, legal, political, and scientific trends in biotechnology Thu, 09 Feb 2012 15:32:22 +0000 hourly 1 http://wordpress.org/?v=3.3 http://www.biotechblog.com/2007/03/27/the-commercial-prospects-of-biogenerics-how-much-will-they-save/comment-page-1/#comment-7518 An appeal for generic biologic legislation | Biotech Blog Mon, 15 Dec 2008 22:25:31 +0000 http://www.biotechblog.com/2007/03/27/the-commercial-prospects-of-biogenerics-how-much-will-they-save/#comment-7518 [...] posted previously on the challenges of developing a framework for generic biologic approvals and questioned how much we can really expect to save. In the editorial for the upcoming issue of the Journal of Commercial Biotechnology, I argue that [...] [...] posted previously on the challenges of developing a framework for generic biologic approvals and questioned how much we can really expect to save. In the editorial for the upcoming issue of the Journal of Commercial Biotechnology, I argue that [...]

]]> http://www.biotechblog.com/2007/03/27/the-commercial-prospects-of-biogenerics-how-much-will-they-save/comment-page-1/#comment-5763 Abhiram Sat, 29 Mar 2008 07:11:07 +0000 http://www.biotechblog.com/2007/03/27/the-commercial-prospects-of-biogenerics-how-much-will-they-save/#comment-5763 I am really fascinated about biosimilars. I have been hearing this for quite some time but no concrete information on the development and establishing bioequivalence. I wonder, if at all they come what kind of product development labs and CRO's they would be needing.? I am really fascinated about biosimilars. I have been hearing this for quite some time but no concrete information on the development and establishing bioequivalence. I wonder, if at all they come what kind of product development labs and CRO’s they would be needing.?

]]> http://www.biotechblog.com/2007/03/27/the-commercial-prospects-of-biogenerics-how-much-will-they-save/comment-page-1/#comment-2327 angie Mon, 09 Apr 2007 01:55:11 +0000 http://www.biotechblog.com/2007/03/27/the-commercial-prospects-of-biogenerics-how-much-will-they-save/#comment-2327 the more I study about biogenerics, the more confused I get. No clear regulatory guidelines with overwhelming inferences. Besides, as you mentioned, it doesn't seem to have any cost-down part of developing process. I think 100%-identical biologic is a mission-impossible, as innovator itself has batch-to-batch variations... well, may be hopeful if FDA gives definition to 'identical' with certain range of compromise. Anyways the overloaded work required for setting the exact same process as innovator or performing comparability study and complex clinical tests won't promise the advantages of generic drug's. I guess that's why many of biogeneric companies are aming 'follow-on' (later generation) and filing as 'stand-alone'? What do you say? the more I study about biogenerics, the more confused I get. No clear regulatory guidelines with overwhelming inferences. Besides, as you mentioned, it doesn’t seem to have any cost-down part of developing process. I think 100%-identical biologic is a mission-impossible, as innovator itself has batch-to-batch variations… well, may be hopeful if FDA gives definition to ‘identical’ with certain range of compromise. Anyways the overloaded work required for setting the exact same process as innovator or performing comparability study and complex clinical tests won’t promise the advantages of generic drug’s. I guess that’s why many of biogeneric companies are aming ‘follow-on’ (later generation) and filing as ‘stand-alone’? What do you say?

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