MAY 01, 2007

New House hearings into proposals to create a fast and clear-cut pathway for the approval of generic biologics produced some mixed signals for generic drug industry leaders who support legislative action in this area.Testifying on behalf of the FDA, Deputy Commissioner Janet Woodcock, MD, told Congress that the agency would welcome generic industry-supported legislation, providing it with additional flexibility to review so-called "follow-on"generic biologic products on a case-by-case basis.

At the same time, however, Dr. Woodcock acknowledged that it could take another 10 years or longer to resolve the scientific roadblocks to implementing a clear-cut pathway for the approval of generic biologics. According to the FDA official, "a number of important issues related to development of such follow-on products also have been identified."

Among them is the "general recognition that the idea of sameness"—the foundation for approving traditional small-molecule generic drugs via abbreviated new drug applications—"will not usually be appropriate for more structurally complex molecules of the type generally licensed as biological products,"she said.

Additionally, Dr. Woodcock cited "clearly scientific challenges involved in determining that a molecule that is not the same as an approved or licensed version is nevertheless similar enough that the agency's conclusions about the safety and effectiveness of the approved or licensed version could be relied on to support approval of the follow- on product."

Despite these cautionary conclusions, officials at the Generic Pharmaceutical Association (GPhA) characterized Dr. Woodcock's testimony as "good news"for "countless patients seeking safe, effective, and affordable biogenerics."

According to Kathleen Jaeger, GPhA president and chief executive officer, the FDA testimony made it clear that the agency "has the scientific expertise to review these lifesaving medicines,"and that "the same scientific principles that apply to the review of changes made to brand products after approval would also be the underpinning for the review of biogenerics."