14 Years of Market Exclusivity Unnecessary, says FTC

A 12- to 14-year market exclusivity period is unnecessary to promote innovation by pioneer biologic drug manufacturers, says The Federal Trade Commission (FTC) in a new report. Innovator companies will retain 70-90% market share even after follow-on biologics (FOBs) enter the market, according to the report. It will take eight to 10 years to develop an FOB at a cost of between $100 million and $200 million each, which probably will limit the number of FOB competitors to as few as three products per innovator biologic.

The report, entitled "Follow-on Biologic Drug Competition" examines whether the price of biologics is likely to be reduced by competition from FOBs. In large part, the report compares potential entry and competition by FOBs with entry and competition by small-molecule pharmaceuticals. The report states that FOBs are likely to have difficulty growing their market shares as rapidly as generic small-molecule drug products typically do.

The lack of automatic substitution between an FOB product and a pioneer biologicdrug will slow the rate at which an FOB product can acquire market share and therebyincrease its revenues, according to the FTC report. An FOB drug also may have difficulty gaining market share because of concerns about safety and efficacy differences between a pioneer biologic drug and the competing FOB.

The 120-page report concludes that patent protection and market-based pricing will promote competition from FOBs, as well as spur biologic innovation. It states that legislation to establish a process for abbreviated FDA approval of FOBs probably is an efficient way to bring FOBs to market because it would save manufacturers time and money.

The FTC report is the result of a roundtable held in November 2008 and public comment on competitive issues involving FOBs. The report comes at a time when Congress is poised to consider FOB legislation with varying periods of market exclusivity. Earlier this year, two competing biosimilar bills were introduced by Rep. Henry Waxman (D–CA) and Rep. Anna G. Eshoo (D–CA) into the US House of Representatives for FOBs. Under the Waxman bill, a new biologic product could receive a maximum of 5.5 years of market exclusivity before an FOB could be approved, whereas the Eshoo bill would provide for up to 14.5 years of market exclusivity for a new biologic product.

View the complete FTC report