[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.
Ronald A. Rader
Biotechnology Information Institute
1700 Rockville Pike, Suite 400
Rockville, MD 20852
E-mail: biotech at biopharma.com
Web sites: www.bioinfo.com; www.biopharma.com;
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