Unlike the more common "small-molecule" drugs, biologics generally exhibit high molecular complexity, and may be quite sensitive to manufacturing process changes. The follow-on manufacturer does not have access to the originator's molecular clone and original cell bank, nor to the exact fermentation and purification process. Finally, nearly undetectable differences in impurities and/or breakdown products are known to have serious health implications. This has created a concern that copies of biologics might perform differently than the original branded version of the drug. However, similar concerns also apply to any production changes by the maker of the original branded version. So new versions of biologics are not authorized in the US or the European Union through the simplified procedures allowed for small molecule generics.
While the term 'biosimilar' or 'follow-on biologics' are getting popular, other terms may also be used in one way or another. Other terms include 'biogenerics', 'generic biologics',...
The Obama administration supports the use and introduction of generic drugs into the market. In his new budget proposal, Obama calls for generic biotech drugs (see CNBC news or forbes news).
on November 21, 2008, FTC held a Roundtable on Follow-on Biologic Drugs: Framework For Competition and Continued Innovation. This workshop signals continuing interest in the issue. The trascript and the videos are available from the website.
Some other readings:
- Schellekens's paper titled "When biotech proteins go off-patent" (trend in biotechnology 2006)
- Amgen CEO assess the generic threat
- Two house members introduce bill to allow FDA to approve generic biotech drugs
- Future of biotechnology (foxbusiness.com)