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
Posted on Fri, Jun 19, 2009 @ 03:39 PM
Where is legislation on biosimilars heading? How will this impact 
innovator biopharmaceutical and biotechnology companies? What is your position on the issue?
Please read my primer on the coming storm of biosimilars published in this month’s Pharmaceutical Executive. http://tinyurl.com/l64pe4
This piece provides a summary overview of the situation and communication strategies to help innovator companies prepare and communicate around this issue.
-- John Kouten