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The Generic Pharmaceutical Association (GPhA) applauded the FDA for confirming the science underlying generic biopharmaceuticals and moving closer to creating definitive requirements to approve these medicines. The green light for generic biopharmaceuticals would yield a significant cost savings.
"There is no reason to delay consumer access to affordable medicines when sound science supports the approval of biopharmaceuticals under a shortened and less costly pathway,"said Kathleen Jaeger, president and chief executive officer of GPhA, during an FDA-Drug Information Association public discussion on the issue. "It is possible to permit approval and marketing of a vast array of biopharmaceuticals with relatively low-to-modest complexity, and to expand that system in the coming years to permit the approval of more complex products,"she added.
Statistics support the economic need for more affordable versions of biopharmaceuticals. Currently, available biopharmaceutical products account for ~$30 billion in US sales and 12% of total pharmaceuticals. The figure is expected to more than double in 2010, with sales exceeding $60 billion. Because of their high costs, biopharmaceuticals will use a higher percentage of health care expenditures in the future and significantly burden health care purchasers, including employers and consumers.