In addition to the Congressional bill, a group of governors petitioned the FDA last summer, urging it to release its guidelines for the approval of follow-on biologics, which the agency began in 2002. The petition was supported by various consumer groups and the Generic Pharmaceutical Association, but the agency has not yet responded.
News
Generic Biologics Still on Congress' Radar Screen : A bill that would allow for the production of generic insulin likely would not affect most insulin users.
Publish date: February 1, 2007