[Ip-health] FDA Biosimilars/Biopharmaceuticals Naming Proposal Fails on Basic Principles and Incoherency

Biotech. Info. Inst. biotech at biopharma.com
Fri Aug 28 07:07:16 PDT 2015


FDA has finally issued a proposed guidance concerning biosimilar product names.  Actually, the proposal is much broader, with new more unique/distinct names to be assigned to all biologics past, present and future.  

However, the proposal is simply abysmal, technically and for many other reasons.  See my critique at http://www.biopharmacopeia.com/FDA_naming_critique.html. 

Thank you.

Ronald A. Rader
President 
Biotechnology Information Institute
1700 Rockville Pike, Suite 400
Rockville, MD 20852
Phone:  301-424-0255
E-mail:  biotech at biopharma.com
Web sites:  www.bioinfo.com; www.biopharma.com; 
   www.biosimilarspipeline.com; www.biopharmacopeia.com




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