Comments on: Similar Biologics http://www.jnjbtw.com/2007/07/similar-biologics/ Our People and Perspectives Wed, 08 Feb 2012 20:15:35 +0000 hourly 1 http://wordpress.org/?v=3.3 By: Ashritha (infoalcpl@gmail.com) http://www.jnjbtw.com/2007/07/similar-biologics/comment-page-1/#comment-24805 Ashritha (infoalcpl@gmail.com) Thu, 07 Oct 2010 12:59:49 +0000 http://jnjbtw.com/?p=60#comment-24805 My colleagues and I have authored what we believe is India’s first ever complete mapping of the Biosimilars opportunity in India. The report is nowbeing made available to the general public. Various issues have been dealt with, such as: - Patent expirations - Regulatory frameworks - Infrastructure Requirements - Etc. If anyone is interested in this report, please contact me at (infoalcpl@gmail.com), and I would send you the brochure and other details. My colleagues and I have authored what we believe is India’s first ever complete mapping of the Biosimilars opportunity in India. The report is nowbeing made available to the general public.
Various issues have been dealt with, such as:
- Patent expirations
- Regulatory frameworks
- Infrastructure Requirements
- Etc.
If anyone is interested in this report, please contact me at (infoalcpl@gmail.com), and I would send you the brochure and other details.

]]> By: David Hamilton http://www.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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