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Although other countries have already moved forward with systemsto facilitate marketing approval of generic "follow-on"biologicproducts, the Generic Pharmaceutical Association (GPhA)warned Congress against patterning a US approach after thoseused abroad. In testimony before the Senate Committee onHealth, Education, Labor, and Pensions, Kathleen Jaeger, GPhApresident and chief executive officer, outlined a series of principlesthat should guide the development of a biodrug approval systemfor the United States.

"While it is useful to examine and apply the positive and negativelessons learned from other nations that have entered into thegeneric biopharmaceutical market, we must take into account theuniqueness of the US health care market,"she told the Senate.Specifically, Jaeger said that, in creating apathway for the introduction of generic biodrugs,the United States should be guided by4 principles: ensuring interchangeability;ensuring safety and efficiency that bring biogenericsto consumers in a timely fashion;promoting sound science that encompassesscientific and technological advances; andfostering a robust competitive pro-consumer generic market.

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

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