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Biogenerics Will Save Billions, Says Hospira CEO

Friday, September 7, 2007 General News
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WASHINGTON, Sept. 6 Expensive biologic medicinesare arriving at a critical crossroads as decades-old patents expire, andgeneric companies stand ready to add biogenerics to the industry's portfolio.Now is the time to pass legislation enabling the U.S. Food and DrugAdministration (FDA) to create an abbreviated regulatory pathway for safe,pure and effective biogenerics, Hospira CEO and Chairman Christopher Begleysaid today in a keynote address at the Generic Pharmaceutical Association's(GPhA) Annual Policy Conference.
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Biologic medicines, unlike traditional pharmaceuticals, are manufacturedfrom complex living cells. They provide some of the most effective treatmentoptions 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) Somebiologics can cost up to $200,000 annually.(2)
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"When life-saving drugs are not affordable -- regardless of their safetyand 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 healthcarespending: (3,4)

Taking the stage in Washington, in front of approximately 200 attendees,Begley said when the technology exists today to create effective, safe andless expensive biogenerics, the continual lack of an approval process is acritical policy issue.

"Creating an approval pathway for safe and effective biogenerics is notonly a fiscally responsible choice, but also a socially responsible one," hesaid. "We know biogenerics will not only save lives, but they will also savethe federal government and society billions of dollars."

Begley underscored the generic industry's eagerness and readiness to bringadditional 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 globalleadership in generic injectable pharmaceuticals. For example, Hospira:

Begley reminded his audience that back in the early 1980s, many viewed theidea of approving traditional or small-molecule generic pharmaceuticals -- thegenerics that have since become ubiquitous -- with suspicion and fear. Safetyand savings were questioned, and the specter of stifled innovation was raised.None of these fears were realized. Unquestionably, generics have dramaticallyreduced the cost of healthcare for millions.

"We're at a similar turning point now," Begley said. "The creation of abiogenerics market in the United States should not be a divisive issue. It isnot about branded versus generic drug companies, or small companies versus bigones. It's about healthy competition and safe, affordable options. It's aboutdoing the right thing for patients and the nation."

About Hospira

Hospira, Inc. is a global specialty pharmaceutical and medication deliverycompany dedicated to Advancing Wellness(TM) by developing, manufacturing andmarketing products that help improve the productivity, safety and efficacy ofpatient care. In February 2007, Hospira acquired Mayne Pharma Limited tobecome the world leader in specialty generic injectable pharmaceuticals. With70 years of service to the hospital industry, Hospira's portfolio includes oneof the industry's broadest lines of generic acute-care and oncologyinjectables, 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 approximately15,000 employees worldwide. Hospira's news releases and other information canbe found at http://www.hospira.com.

For additional background on the pending biogenerics legislation, visit:

-- The Generic Pharmaceutical Association - "Biogenerics" sectionhttp://www.gphaonl
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