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- GPhA Keynote Emphasizes Generic Industry Readiness and Questions Fiscal
and Social Responsibility of Delaying Biogenerics -
WASHINGTON, Sept. 6 /PRNewswire-FirstCall/ -- Expensive biologic medicines are arriving at a critical crossroads as decades-old patents expire, and generic companies stand ready to add biogenerics to the industry's portfolio. Now is the time to pass legislation enabling the U.S. Food and Drug Administration (FDA) to create an abbreviated regulatory pathway for safe, pure and effective biogenerics, Hospira CEO and Chairman Christopher Begley said today in a keynote address at the Generic Pharmaceutical Association's (GPhA) Annual Policy Conference.
Biologic medicines, unlike traditional pharmaceuticals, are manufactured from complex living cells. They provide some of the most effective treatment options for serious diseases like cancer and diabetes, but are very expensive. A biologic to treat colon cancer, for example, costs $100,000 a year.(1) Some biologics can cost up to $200,000 annually.(2)
"When life-saving drugs are not affordable -- regardless of their safety and efficacy -- they are irrelevant," Begley said.
Representing about 250 of the more than 10,000 drugs approved by the FDA, branded biologics claim a disproportionate share of the nation's healthcare spending: (3,4)
-- In 2006, sales of biologics rose to the $30 to $40 billion range,
accounting for about 15 percent of all U.S. drug sales. (2,5)
-- In 2006, biologics cost Medicare Part B alone more than
$5 billion.(2)
-- Corporations have testified before Congress that they can't continue
to sustain the growing contribution of biologics to their employee
healthcare costs.(6)
Taking the stage in Washington, in front of approximately 200
attendees, Begley said when the technology exists today to create
effective, safe and less expensive biogenerics, the continual lack of a
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