Congressional Bill Establishes Biogenerics Approval Path

February 15, 2007
Pharmaceutical Technology Editors
ePT--the Electronic Newsletter of Pharmaceutical Technology

Washington, DC (Feb. 14)?A congressional team has reintroduced the ?Access to Life-Saving Medicine Act,? which establishes a process through which the US Food and Drug Administration can approve generic copies of biologic drugs.

Washington, DC (Feb. 14)-A congressional team has reintroduced the “Access to Life-Saving Medicine Act,” which establishes a process through which the US Food and Drug Administration (FDA, Rockville, MD, www.fda.gov) can approve generic copies of biologic drugs. Some congressional leaders are calling for the bill to be attached to the Prescription Drug User Fee Act, slated for reapproval this year, but no plans for this have been set. If approved, the act would provide FDA with the process for comparing biogenerics and the respective innovator drugs without the need for the generics firm to conduct clinical trials.

The bill was proposed during a previous session of Congress, but because the bill was not passed at the end of the session, it had to be reintroduced.

Under this law, FDA would have the “discretionary authority in selecting certain studies and tests needed to approve biogenerics or follow-on drugs.”

On his Web site, Rep. Henry Waxman (D-CA) stated, “Introducing fair competition for biotech drugs is essential to keep life-saving treatments affordable.” The Generic Pharmaceutical Association also has stated its strong support of the bill, saying it will provide an abbreviated approval pathway for safe, effective, and affordable biogenerics to consumers.