- 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
-- Corporations have testified before Congress that they can't continue
to sustain the growing contribution of biologics to their employee
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 an approval process is a critical policy issue.
"Creating an approval pathway for safe and effective biogenerics is not only a fiscally responsible choice, but also a socially responsible one," he said. "We know biogenerics will not only save lives, but they will also save the federal government and society billions of dollars."
Begley underscored the generic industry's eagerness and readiness to bring additional financial relief to the American people in the form of safe, effective, quality-driven biogenerics.
Hospira's entrance into biogenerics is a natural extension of its global leadership in generic injectable pharmaceuticals. For example, Hospira:
-- is actively developing six biogenerics, one through a collaboration
with STADA and BIOCEUTICALS to provide a generic erythropoietin;
-- acquired Australia-based BresaGen to enhance the company's protein and
peptide manufacturing and cell development capabilities; and
-- has internal expertise in biologic formulation and fill-and-finish
manufacturing through its contract manufacturing business, which makes
branded biologics for the world's leading biotech companies.
Begley reminded his audience that back in the early 1980s, many viewed the idea of approving traditional or small-molecule generic pharmaceuticals -- the generics that have since become ubiquitous -- with suspicion and fear. Safety and savings were questioned, and the specter of stifled innovation was raised. None of these fears were realized. Unquestionably, generics have dramatically reduced the cost of healthcare for millions.
"We're at a similar turning point now," Begley said. "The creation of a biogenerics market in the United States should not be a divisive issue. It is not about branded versus generic drug companies, or small companies versus big ones. It's about healthy competition and safe, affordable options. It's about doing the right thing for patients and the nation."
Hospira, Inc. is a global specialty pharmaceutical and medication delivery company dedicated to Advancing Wellness(TM) by developing, manufacturing and marketing products that help improve the productivity, safety and efficacy of patient care. In February 2007, Hospira acquired Mayne Pharma Limited to become the world leader in specialty generic injectable pharmaceuticals. With 70 years of service to the hospital industry, Hospira's portfolio includes one of the industry's broadest lines of generic acute-care and oncology injectables, which help address the high cost of proprietary pharmaceuticals; and integrated solutions for medication management and infusion therapy. Headquartered north of Chicago in Lake Forest, Ill., Hospira has approximately 15,000 employees worldwide. Hospira's news releases and other information can be found at http://www.hospira.com.
For additional background on the pending biogenerics legislation, visit:
-- The Generic Pharmaceutical Association - "Biogenerics" section http://www.gphaonline.org/AM/Template.cfm?Section=FDA_Science&CONTENTID=194 8&T EMPLATE=/CM/HTMLDisplay.cfm
-- The Coalition for a Competitive Pharmaceutical Market -- "Legislative Backgrounders" section: http://www.therightprescription.org/site/second/rx_resources
(1) Pollack, Andrew. "Genentech Caps Cost of Cancer Drug for Some
Patients." The New York Times 12 Oct. 2006.
(2) "Coalition for a Competitive Pharmaceutical Marketplace Supports
Biogenerics backgrounder." Coalition for a Competitive Pharmaceutical
(3) Healthcare overview. Biotechnology Industry Organization.
4 Sept. 2007 < http://www.bio.org/healthcare/ >.
(4) New Drug Application Approvals and Receipts, Including New Molecular
Entities, 1938 to Present. U.S. Food and Drug Administration. 5 Sept.
(5) Harbour, Jones. Federal Trade Commission: The Competitive
Implications of Generic Biologics. San Francisco. 14 June 2007.
(6) Senate Special Committee on Aging. 109th United States Congress,
Washington. 20 July 2006. Mark Merritt.
|SOURCE Hospira, Inc.|
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