Comments on: When will the U.S. develop concise generic biologic rules? http://www.biotechblog.com/2008/09/22/when-will-the-us-develop-concise-generic-biologic-rules/ Commercial, legal, political, and scientific trends in biotechnology Thu, 09 Feb 2012 15:32:22 +0000 hourly 1 http://wordpress.org/?v=3.3 By: Ron Rader http://www.biotechblog.com/2008/09/22/when-will-the-us-develop-concise-generic-biologic-rules/comment-page-1/#comment-6867 Ron Rader Wed, 24 Sep 2008 15:06:38 +0000 http://www.biotechblog.com/?p=743#comment-6867 Regarding your opinion that biosimilars/follow-on biologics regulation is not an area where the U.S. can or should lead, this is not really a concern. On the contrary, the U.S. needs to catch-up to much of the rest of the world. The European Union has instituted a rather well thought-out mechanism for abbreviated approvals of biosimilars and has approved multiple products, and much of the rest of the world, including Canada, Japan, Brazil are in the process of implementing (or are much further along compared to the U.S.) regulatory regimes following the EU model (which almost certainly will be the one adopted/adapted in the U.S.). And for the rest of the the world (lesser-developed countries), the World Health Org. (WHO, UN) is developing guidelines for adoption by these countries. This involves two tracks for product approval -- a rigorous one based on the EU model and an as yet ill-defined one that many believe will simply allow/codify any/all approvals, including non-GMP and other low (or no) quality products currently in these markets, domestically-produced knock-offs, etc. If the U.S. does not get its act together soon, e.g., pass enabling legislation in the next session of Congress, the U.S. will be largely left out of the opportunities, including corporate profits and consumer savings, biosimilars offer; and lacking U.S. leadership, there is a substantial risk that any second-tier regulatory system proposed by WHO may be adopted by many countries. Otherwise, in terms of a timeline for Congressional action on biosimilars-enabling legislation, from attending the "Biosimilars 2008" conference the past two days, with speakers including Senators Hatch and Waxman, and Rep. Eshoo, sponsors of various proposed bills, and various Congressional staff, lobbyists, etc., there is consensus that Congress will act next session. Both presidential candidates favor biosimilar-enabling legislation, and as discussed above, there is increasing recognition that the U.S. needs to get its act together. The main remaining details to be worked out are granting of exclusivity (or not) to innovator products, and, if granted, how many years; and how to deal with patent dispute resolutions. Most everyone assumes political compromises will occur in these areas. Ronald A. Rader President Biotechnology Information Institute 1700 Rockville Pike, Suite 400 Rockville, MD 20852 Phone:  301-424-0255 E-mail:  ron@biopharma.com Web sites:  www.bioinfo.com; www.biopharma.com;       www.biopharmacopeia.com; www.biosimilars.com Regarding your opinion that biosimilars/follow-on biologics regulation is not an area where the U.S. can or should lead, this is not really a concern. On the contrary, the U.S. needs to catch-up to much of the rest of the world. The European Union has instituted a rather well thought-out mechanism for abbreviated approvals of biosimilars and has approved multiple products, and much of the rest of the world, including Canada, Japan, Brazil are in the process of implementing (or are much further along compared to the U.S.) regulatory regimes following the EU model (which almost certainly will be the one adopted/adapted in the U.S.). And for the rest of the the world (lesser-developed countries), the World Health Org. (WHO, UN) is developing guidelines for adoption by these countries. This involves two tracks for product approval — a rigorous one based on the EU model and an as yet ill-defined one that many believe will simply allow/codify any/all approvals, including non-GMP and other low (or no) quality products currently in these markets, domestically-produced knock-offs, etc. If the U.S. does not get its act together soon, e.g., pass enabling legislation in the next session of Congress, the U.S. will be largely left out of the opportunities, including corporate profits and consumer savings, biosimilars offer; and lacking U.S. leadership, there is a substantial risk that any second-tier regulatory system proposed by WHO may be adopted by many countries.

Otherwise, in terms of a timeline for Congressional action on biosimilars-enabling legislation, from attending the “Biosimilars 2008″ conference the past two days, with speakers including Senators Hatch and Waxman, and Rep. Eshoo, sponsors of various proposed bills, and various Congressional staff, lobbyists, etc., there is consensus that Congress will act next session. Both presidential candidates favor biosimilar-enabling legislation, and as discussed above, there is increasing recognition that the U.S. needs to get its act together. The main remaining details to be worked out are granting of exclusivity (or not) to innovator products, and, if granted, how many years; and how to deal with patent dispute resolutions. Most everyone assumes political compromises will occur in these areas.

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

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