http://www.biotechblog.com/2007/03/05/why-are-biogenerics-so-hard-to-regulate/ Commercial, legal, political, and scientific trends in biotechnology Wed, 03 Mar 2010 20:01:20 +0000 http://wordpress.org/?v=2.9.1 hourly 1 http://www.biotechblog.com/2007/03/05/why-are-biogenerics-so-hard-to-regulate/comment-page-1/#comment-6863 eda Tue, 23 Sep 2008 15:39:55 +0000 http://www.biotechblog.com/2007/03/05/why-are-biogenerics-so-hard-to-regulate/#comment-6863 wat r diferent between biogenerics and biosimilar...help me .... wat r diferent between biogenerics and biosimilar…help me ….

]]> http://www.biotechblog.com/2007/03/05/why-are-biogenerics-so-hard-to-regulate/comment-page-1/#comment-6862 When will the U.S. develop concise generic biologic rules? | Biotech Blog Mon, 22 Sep 2008 19:06:04 +0000 http://www.biotechblog.com/2007/03/05/why-are-biogenerics-so-hard-to-regulate/#comment-6862 [...] I’ve described before, regulating generic biologics is no easy feat. A good regulatory scheme must address safety issues while enabling productive competition. Failure [...] [...] I’ve described before, regulating generic biologics is no easy feat. A good regulatory scheme must address safety issues while enabling productive competition. Failure [...]

]]> http://www.biotechblog.com/2007/03/05/why-are-biogenerics-so-hard-to-regulate/comment-page-1/#comment-5702 Patent Baristas » Can Approval of Biogenerics Really Save Money? Tue, 19 Feb 2008 16:48:53 +0000 http://www.biotechblog.com/2007/03/05/why-are-biogenerics-so-hard-to-regulate/#comment-5702 [...] See also:  Why are biogenerics so hard to regulate? [...] [...] See also:  Why are biogenerics so hard to regulate? [...]

]]> http://www.biotechblog.com/2007/03/05/why-are-biogenerics-so-hard-to-regulate/comment-page-1/#comment-5673 smaranya.com » An appeal for generic biologic legislation Mon, 11 Feb 2008 01:35:07 +0000 http://www.biotechblog.com/2007/03/05/why-are-biogenerics-so-hard-to-regulate/#comment-5673 [...] 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 [...] [...] 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 [...]

]]> http://www.biotechblog.com/2007/03/05/why-are-biogenerics-so-hard-to-regulate/comment-page-1/#comment-5670 Biotech Blog » An appeal for generic biologic legislation Sun, 10 Feb 2008 20:02:40 +0000 http://www.biotechblog.com/2007/03/05/why-are-biogenerics-so-hard-to-regulate/#comment-5670 [...] 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 [...] [...] 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 [...]

]]> http://www.biotechblog.com/2007/03/05/why-are-biogenerics-so-hard-to-regulate/comment-page-1/#comment-3952 Biolovepulse Wed, 13 Jun 2007 10:29:49 +0000 http://www.biotechblog.com/2007/03/05/why-are-biogenerics-so-hard-to-regulate/#comment-3952 Because biological drugs are produced by living (cellular) processes itself, we need to take into consideration like final structure of the protein or modification of the protein to determine the function of the protein (which is the drug) in the body. As it's harder to control this process, I think this is also one of the reason which make biogeneric regulation difficult. Because biological drugs are produced by living (cellular) processes itself, we need to take into consideration like final structure of the protein or modification of the protein to determine the function of the protein (which is the drug) in the body. As it’s harder to control this process, I think this is also one of the reason which make biogeneric regulation difficult.

]]> http://www.biotechblog.com/2007/03/05/why-are-biogenerics-so-hard-to-regulate/comment-page-1/#comment-592 Biotech Blog » The commercial prospects of biogenerics - how much will they save? Tue, 27 Mar 2007 05:28:19 +0000 http://www.biotechblog.com/2007/03/05/why-are-biogenerics-so-hard-to-regulate/#comment-592 [...] Why are biogenerics so hard to regulate? [...] [...] Why are biogenerics so hard to regulate? [...]

]]> http://www.biotechblog.com/2007/03/05/why-are-biogenerics-so-hard-to-regulate/comment-page-1/#comment-287 BiotechBlog Thu, 15 Mar 2007 17:37:55 +0000 http://www.biotechblog.com/2007/03/05/why-are-biogenerics-so-hard-to-regulate/#comment-287 Followup: I don't believe I said that biologics are "too complex" or implied that a regulatory pathway is an impossibility. Followup: I don’t believe I said that biologics are “too complex” or implied that a regulatory pathway is an impossibility.

]]> http://www.biotechblog.com/2007/03/05/why-are-biogenerics-so-hard-to-regulate/comment-page-1/#comment-286 Editor Thu, 15 Mar 2007 17:28:58 +0000 http://www.biotechblog.com/2007/03/05/why-are-biogenerics-so-hard-to-regulate/#comment-286 We have run a couple of very interesting articles on this topic. I believe that you are oversimplifying it here by saying simply that biologics are too complex. I encourage blog readers to check out the articles we have run (Registration is required, but it won't cost a thing!) on the topic, providing some numbers on "biosimilars", "follow-on biologics," or "biogenerics" that have already been approved an produced in other countries. This is just a matter of time, not an impossibility. We have run a couple of very interesting articles on this topic. I believe that you are oversimplifying it here by saying simply that biologics are too complex. I encourage blog readers to check out the articles we have run (Registration is required, but it won’t cost a thing!) on the topic, providing some numbers on “biosimilars”, “follow-on biologics,” or “biogenerics” that have already been approved an produced in other countries. This is just a matter of time, not an impossibility.

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