UPDATE: GPhA welcomes FTC move on biogenerics

Responding to the recent US Federal Trade Commission's roundtable on Emerging Health Care Competition and Consumer Issues, which addressed the contentious subject of follow-on biologic drugs, the Generic Pharmaceutical Association's chief executive, Kathleen Jaeger, said: "the mere fact that the FTC is conducting this roundtable demonstrates the growing momentum behind ensuring that consumers have access to safe and affordable biogenerics sooner rather than later."

New Admin focus likely

Details of the discussions or conclusions of the meeting have not been released publicly by the agency. However, finding a pathway for the approval of follow-on biologics, or biosimilars, in the USA is likely to be a focus of the new Administration of President-elect Barack Obama, with the expectation that the market exclusivity for patented biological drugs will be shorter than the 14 years called for by the research-based Biotechnology Industry Organization but backed by the GPhA (Marketletters passim). Estimates of the potential cost-savings through biosimilars has been estimated at $14.0 billion-$108.0 billion over a 10-year period.