The Follow-on Biologics Debate and the June 2009 FTC Report on Follow-on Biologic Drug Competition

On June 10, 2009, the Federal Trade Commission released a detailed report entitled: “Emerging Health Care Issues: Follow-on Biologic Drug Competition.”  The FTC Report is important because it provides the most current government-sector analysis of the U.S. biologics market and the FTC’s recommendations for legislation designed to allow for “follow-on” versions of such drug products. The FTC Report suggests that legislation granting the FDA the authority to approve follow-on biologics is an “efficient” way to bring these products to market. There is considerable tension, however, between the FTC’s recommendations and the two follow-on biologics bills recently introduced in Congress.

For EAPD’s full advisory on this issue, please click here.