FDA SUPPORTS NEW BIOLOGIC LEGISLATION

New House hearings into proposals tocreate a fast and clear-cut pathway for theapproval of generic biologics producedsome mixed signals for generic drug industryleaders who support legislative actionin this area.Testifying on behalf of the FDA,Deputy Commissioner Janet Woodcock,MD, told Congress that the agency wouldwelcome generic industry-supported legislation,providing it with additional flexibilityto review so-called "follow-on"genericbiologic products on a case-by-case basis.

At the same time, however, Dr. Woodcockacknowledged that it could takeanother 10 years or longer to resolve thescientific roadblocks to implementing aclear-cut pathway for the approval ofgeneric biologics. According to the FDAofficial, "a number of important issuesrelated to development of such follow-onproducts also have been identified."

Among them is the "general recognitionthat the idea of sameness"—the foundationfor approving traditional small-moleculegeneric drugs via abbreviated newdrug applications—"will not usually beappropriate for more structurally complexmolecules of the type generally licensed asbiological products,"she said.

Additionally, Dr. Woodcock cited "clearlyscientific challenges involved in determiningthat a molecule that is not the same as anapproved or licensed version is neverthelesssimilar enough that the agency's conclusionsabout the safety and effectivenessof the approved or licensed version couldbe relied on to support approval of the follow-on product."

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

According to Kathleen Jaeger, GPhApresident and chief executive officer, theFDA testimony made it clear that theagency "has the scientific expertise toreview these lifesaving medicines,"andthat "the same scientific principles thatapply to the review of changes made tobrand products after approval would alsobe the underpinning for the review of biogenerics."