Request for Comments and Announcement of Public Workshop Follow-On Biologics: Impact of Recent Legislative and Regulatory Naming Proposals on Competition #00013

Submission Number:
00013
Commenter:
Ronald A. Rader
Organization:
Biotechnology Information Institute
State:
Maryland
Initiative Name:
Request for Comments and Announcement of Public Workshop Follow-On Biologics: Impact of Recent Legislative and Regulatory Naming Proposals on Competition
Matter Number:

P131208

An article I authored, "Nomenclature of Biosimilars Will Be Highly Controversial," from BioProcess International, June 2011, is attached. This article takes a somewhat more broader and longer-term view than the narrow, limited, vested interest-driven submissions most everyone has been providing. As I note, resolution of the current issue involving highly regulatory-constrained official nonproprietary names does not solve many of the basic nomenclature-related problems that will continue to plague the biopharmaceutical industry. Basic problems remain, including that biopharmaceutical products and active agents lack both usable unique/distinct and (bio)generic/biosimilar/class-type names, which obviously are needed (but not for use as regulatory-constrained official names). FDA has avoided assigning unique/distinct names to approved products for over 100 years; and now with biosimilars, (bio)generic/biosimilar/class-type name are also needed. Please note this in your final report. Thank you. Ronald A. Rader President Biotechnology Information Institute 1700 Rockville Pike, Suite 400 Rockville, MD 20852 Phone: 301-424-0255 Web sites: www.biopharma.com; www.bioinfo.com; www.biosimilarspipeline.com; www.biopharmacopeia.com