When will the U.S. develop concise generic biologic rules?

A lot of people have been asking my opinion on when a concise generic biologic regulatory pathway will emerge in the United States, and I give them all the same answer: Later.

In my opinion complex regulatory schemes are not areas in which the United States can effectively lead. Why not? Because the size of the market makes tracking problems difficult, and implementing regulatory change can be very slow.

As I’ve described before, regulating generic biologics is no easy feat. A good regulatory scheme must address safety issues while enabling productive competition. Failure to accomplish either objective could potentially set the field back by years (consider the field of gene therapy which, despite some early signs of progress, is haunted by the deaths of study subjects).

The United States is the world’s largest pharmaceutical market, and accomplishing regulatory change can be slow. It is not an effective place to experiment with or refine generic biologic approval schemes. That is best left to smaller and more agile countries. Smaller countries often seek opportunities to serve as testbeds for emerging opportunities like alternative fuels, patient tracking, personalized medicine, etc. and will likely be the first places where comprehensive generic biologic regulations emerge (likely supported by consultants and regulators from the U.S. and EU).

The challenge to driving this innovation in smaller countries, however, is that they often lack the very resources necessary to test policy or technology innovations. This is where large nations, the EU, or agencies and organizations such as the WHO, ADB, IMF, etc could be directing their resources to simultaneously help development in smaller nations while supporting innovations offering global benefits, ultimately serving their own interests


  1. Ron Rader
      September 24, 2008

    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
    Biotechnology Information Institute
    1700 Rockville Pike, Suite 400
    Rockville, MD 20852
    Phone:  301-424-0255
    E-mail:  [email protected]
    Web sites:  www.bioinfo.com; www.biopharma.com; 
         http://www.biopharmacopeia.com; http://www.biosimilars.com

    • Dmitry
        March 31, 2016

      biosimilars.com site is offline