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Hospira Ramps Up Competition on Biologic Drug PDF Print E-mail
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Saturday, 24 September 2011 00:39

Though still years behind Europe in the availability of cheaper copycat versions of some of the world’s most expensive prescriptions, savings on expensive drugs derived from biotechnology are inching closer to reality in the United States.

 

Hospira, based in Lake Forest, Ill., which has been selling cheaper versions of expensive biologic drugs in Europe for nearly four years, said on Monday that it would begin a final-stage clinical trial in the United States by the end of this year of its “biosimilar” version of Amgen’s brand-name Epogen in patients with renal dysfunction who have anemia.

The federal health care law opens a regulatory path through the Food and Drug Administration to approve so-called “biogeneric” or “biosimilar” versions of brand-name drugs derived from animal or human cells. Biologic drugs in equivalent forms are unavailable in the United States because they were not part of the 1984 Hatch-Waxman law, which paved the way for cheaper generic copies of prescription drugs derived from chemicals.

Because of the complexity in how biotech drugs are made, brand-name makers of these drugs lobbied successfully when the health care legislation was written to require clinical trials before any could win United States approval. Clinical trials are not required for generic drug makers to win approval of pills and other prescriptions made from small molecules. (On Monday, President Obama pushed for more competition in this field to help reduce drug costs.

Biologics can cost tens, and even hundreds of thousands of dollars a year, for just one patient’s treatment.

Hospira’s version of Epogen, also known as erythropoietin or “EPO,” is called Retacrit in Europe, where patients can get biosimilar drugs that are 20 to 30 percent cheaper than brand names, analysts say. Hospira would not disclose a price for Retacrit in Europe or what it plans to charge in the United States for a drug that currently costs more than $10,000 a year as a brand name.

“Biosimilars is one of the greatest cost savings opportunities out there today for health care systems and for countries,” Hospira’s chief executive, Michael Ball, told Wall Street analysts and investors in a meeting at the company’s Lake Forest headquarters earlier this month.

“Biosimilars are not miracle drugs,” Ball added. “They are real. We are really selling them in Europe, we’re really selling them in Australia and we will be selling them here in the United States.”

In earlier American trials, Hospira said its version of EPO met its crucial endpoint, showing “equal pharmacokinetics” to Amgen’s Epogen.

Hospira’s work means perhaps the most to the United States’ tab for prescription biotech drugs since Epogen has been been the nation’s best selling and therefore costliest biologic since it was marketed.

Though other companies are also working to develop biosimilars and it’s unclear who will bring the first biosimilar to market, Hospira is furthest along than others to bring a biosimilar version of Epogen to patients here in the United States. Epogen was the 10th best-selling brand-name drug here last year with more than $3.3 billion in annual sales, according to the most recent annual sales information from IMS Health.

Companies are not predicting when the first biosimilar will reach patients in the United States in part because the F.D.A. has yet to complete draft guidance on the approval process, though analysts say they could be here by 2014.

Other companies, too, are betting on biosimilars like Israel’s Teva Pharmaceutical Industries and Novartis AG’s Sandoz generic drug-making unit.

“The next 6-12 months should see accelerating news flow around biosimiars,” said a Morgan Stanley analyst Dr. Marshall Urist, in a recent report.

source:Hospira

 
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