Request for Comments and Announcement of Public Workshop Follow-On Biologics: Impact of Recent Legislative and Regulatory Naming Proposals on Competition #00012

Submission Number:
00012
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

The attached article presents data and assessments concerning the biosimilars (and biobetters) development pipeline and likely evolution of the U.S. market. This is based on the most extensive database tracking biosimilars (and biobetters) development worldwide (see www.biosimilarspipeline.com). From my data, I readily conclude that most everyone is considerably underestimating the number of biosimilar players and products that will soon start entering the U.S. market. For example, there could easily be over a dozen versions of most every blockbuster (currently over 40 biopharmaceuticals), meaning the number of approved biologics will grow 3x-4x in a rather short period. As discussed in my other submissions, including the Citizen Petition I filed with FDA, official nonproprietary names are useless in terms of identifying and tracking active agents and products, if only because they are meant to be simple, unchanging and inherently generic (due to lack of specificity). Please keep in mind that the industry and everyone simply need both unique and generic names for biopharmaceutical active agents and products, with these coherent, entity/science/product- and rules-based, and most definitely not official (regulatory-constrained), which means totally new nomenclature. Resolving the official names controversy will still leave many nomenclature-related problems unresolved, with these destined to cause constant problems for industry and consumers, particularly as the number of marketed biologics increases from low 100s to up to 1,000 within just 5-10 years. In terms of resolving the official names controversy, please keep in mind that any nomenclature selected must be able to work for at least as decade, ideally the 21st century (what we need to be aiming for). For example, what name will be assigned in the future to say the 30th approved version of Humira (with this realistic, e.g, splitting 2/3rds of its current $10 billion market 30 ways provides an average market of $220 million/year, a healthy market for a biosimilar). Feel free to contact me, if you have any questions or desire any custom searches of my pipeline database. 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