http://blog.pharmtech.com/2009/02/13/a-view-of-biosimilars-to-come/ The blog of Pharmaceutical Technology magazine Fri, 23 Jul 2010 18:36:30 -0400 http://wordpress.org/?v=2.8.4 hourly 1 http://blog.pharmtech.com/2009/02/13/a-view-of-biosimilars-to-come/comment-page-1/#comment-11899 mary c. Sat, 14 Feb 2009 18:18:05 +0000 http://blog.pharmtech.com/?p=886#comment-11899 A key issue with biotech products is evident not only in the science, but now reflected, importantly in the language. Biosimilar and follow-on are appropriate language which many may not consider or understand the careful selection of this language rather than just calling these generic drugs. The products and processes which in total comprise a biotech drug, could never be considered "identical" due to the nature of biology and complexity of the molecules and the manufacturing. A great analogy, particularly on Valentine's day, would be a chocolate souffle. Presumably I could follow an identical recipe and an identical process, but I'm sure a souffle from my kitchen vs. the Bon Appetit test kitchens would differ importantly. Unfortunately, in the setting of managing life-theatening diseases, much more complex issues around safety, benefit, ethics, cost, etc, further add to the arduous regulatory debate in the US. A key issue with biotech products is evident not only in the science, but now reflected, importantly in the language. Biosimilar and follow-on are appropriate language which many may not consider or understand the careful selection of this language rather than just calling these generic drugs. The products and processes which in total comprise a biotech drug, could never be considered “identical” due to the nature of biology and complexity of the molecules and the manufacturing. A great analogy, particularly on Valentine’s day, would be a chocolate souffle. Presumably I could follow an identical recipe and an identical process, but I’m sure a souffle from my kitchen vs. the Bon Appetit test kitchens would differ importantly. Unfortunately, in the setting of managing life-theatening diseases, much more complex issues around safety, benefit, ethics, cost, etc, further add to the arduous regulatory debate in the US.

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