The Generic Pharmaceutical Association(GPhA) applauded the FDA for confirmingthe science underlying genericbiopharmaceuticals and moving closerto creating definitive requirements toapprove these medicines. The greenlight for generic biopharmaceuticalswould yield a significant cost savings.
"There is no reason to delay consumeraccess to affordable medicineswhen sound science supports theapproval of biopharmaceuticals under ashortened and less costly pathway,"saidKathleen Jaeger, president and chiefexecutive officer of GPhA, during anFDA-Drug Information Associationpublic discussion on the issue. "It is possibleto permit approval and marketingof a vast array of biopharmaceuticalswith relatively low-to-modest complexity,and to expand that system in thecoming years to permit the approval ofmore complex products,"she added.
Statistics support the economicneed for more affordable versions ofbiopharmaceuticals. Currently, availablebiopharmaceutical products accountfor ~$30 billion in US sales and12% of total pharmaceuticals. The figureis expected to more than double in2010, with sales exceeding $60 billion.Because of their high costs, biopharmaceuticalswill use a higher percentageof health care expenditures in thefuture and significantly burden healthcare purchasers, including employersand consumers.