As Ed Silverman explains in Pharmalot, the FDA sent back Teva's application for a generic (biosimilar) form of Amgen's Neupogen. Teva had submitted their drug, called Neutroval, under a traditional approval pathway for a biologic. The FDA declined it, however as stated in Teva's press release, the agency is requiring more data but is NOTrequiring more clincal trials to complete its review. (See WSJ article too)This, along with the agency's approval of the generic form of Lovenox earlier this year, suggests the FDA may be more amenable to licensing generic biologics and biosimilars than perhaps previously thought.
Teva's Neutroval has already been approved in Europe since 2008 - but the FDA has yet to outline the pathway for submission and approval for biosimilars in the US. The Healthcare reform bill in March however did lay the groundwork for biosimilars.
The Patent Doc blog reminds us that the FDA will hold public hearings on Nov. 2nd and 3rd to obtain input from stakeholders on the agency's implementation of the Biologics Price Competition and Innovation Act of 2009 (BPCIA), the portion of the Patient Protection and Affordable Care Act (PPACA) that creates an abbreviated approval pathway for biosimilars (like Neutroval) and interchangeable biological products (like M-Enoxaparin). See Patent Doc blog for more details on issues FDA is seeking comment on.