Comments on: Similar Biologics http://jnjbtw.com/2007/07/similar-biologics/ Our People and Perspectives Thu, 11 Mar 2010 19:28:18 +0000 http://wordpress.org/?v=2.9.1 hourly 1 By: David Hamilton http://jnjbtw.com/2007/07/similar-biologics/comment-page-1/#comment-72 David Hamilton Tue, 14 Aug 2007 03:12:49 +0000 http://jnjbtw.com/?p=60#comment-72 Of course, branded biologics aren't the "same" when produced in different facilities, either -- just ask Genzyme about its so-far unapproved Myozyme manufacturing line in Boston. Oddly, though, I haven't heard J&J or anyone else arguing that Genzyme needs to run clinical trials to ensure that the "new" Myozyme is the same as the "old" Myozyme -- instead, everyone seems content to let Genzyme tinker with the process until it passes a battery of simpler and less expensive assays and convinces the FDA that different batches of the protein are equivalent. Why would it be a problem for would-be biogenerics makers to do exactly the same thing? Otherwise, I'm not sure why I'm not sure I see why different batches of Myozyme in this instance shouldn't also be tagged as "biosimilars," at least by the logic of this post. Of course, branded biologics aren’t the “same” when produced in different facilities, either — just ask Genzyme about its so-far unapproved Myozyme manufacturing line in Boston. Oddly, though, I haven’t heard J&J or anyone else arguing that Genzyme needs to run clinical trials to ensure that the “new” Myozyme is the same as the “old” Myozyme — instead, everyone seems content to let Genzyme tinker with the process until it passes a battery of simpler and less expensive assays and convinces the FDA that different batches of the protein are equivalent.

Why would it be a problem for would-be biogenerics makers to do exactly the same thing? Otherwise, I’m not sure why I’m not sure I see why different batches of Myozyme in this instance shouldn’t also be tagged as “biosimilars,” at least by the logic of this post.

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