This might be interesting regarding the FDA's biosimilar position:
FDA Oncologic Drugs Advisory Committee to hold a meeting The Committee will discuss biologics license application (BLA) 125553 for EP2006, a proposed biosimilar to Amgen Inc.'s NEUPOGEN (filgrastim), submitted by Sandoz, Inc., in a meeting being held at FDA Silver Spring, Maryland offices on January 7 at 8 am.