FDA Speak: Complex Molecules Are Not Biologics
Posted on Mon, Jul 26, 2010 @ 01:47 PM
Could the recent FDA approval of a generic version of Lovenox (enoxaparin) be the beginning of approvals of other complex molecules? We recall that the Biologics Price Competition and 
Innovation Act of 2009 found its way into the Health reform bill. The Biologics Act provides a pathway for biosimilars, however, grants biologics innovator companies 12-years patent exclusivity (http://tiny.cc/ymnj1). While biologics currently reside outside the current generics approval processes, it seems that “complex molecules” like enoxaparin do not. The developers of the generic enoxaparin, Sandoz, division of Novartis, are hoping to win approval next for a generic version of the “complex mixture” Copaxone for the treatment of multiple sclerosis. For more details on FDA’s position visit: http://tiny.cc/fvvve. For more information regarding Sanofi’s position, read their July 23 statement here: http://tiny.cc/zgib3.
--John Kouten