Published Online: Tuesday, May 1, 2007

Although other countries have already moved forward with systems to facilitate marketing approval of generic "follow-on"biologic products, the Generic Pharmaceutical Association (GPhA) warned Congress against patterning a US approach after those used abroad. In testimony before the Senate Committee on Health, Education, Labor, and Pensions, Kathleen Jaeger, GPhA president and chief executive officer, outlined a series of principles that should guide the development of a biodrug approval system for the United States.

"While it is useful to examine and apply the positive and negative lessons learned from other nations that have entered into the generic biopharmaceutical market, we must take into account the uniqueness of the US health care market,"she told the Senate. Specifically, Jaeger said that, in creating a pathway for the introduction of generic biodrugs, the United States should be guided by 4 principles: ensuring interchangeability; ensuring safety and efficiency that bring biogenerics to consumers in a timely fashion; promoting sound science that encompasses scientific and technological advances; and fostering a robust competitive pro-consumer generic market.

"Momentum is clearly growing for biogenerics,"she told Congress. "As working families, employers, and health plans look for ways to reduce health care costs without jeopardizing quality care, they are demanding generics and a pathway for biogenerics."

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