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Case builds for access to biogenerics

The Baltimore Sun

CHICAGO -- Cheaper generic copies of some of the world's most expensive medicines could be on the way - good news for consumers but painful for companies' bottom lines.

Just as the pharmaceutical industry looks more to biotechnology to escape expiring patents and generic competition for chemically derived drugs, a new threat could emerge in 2008: a federal law that allows for cheaper generic copies of biotech medicines.

Some pharmaceutical industry giants already have been hurt by expiring patents on some of the world's top-selling pills.

Merck & Co.'s cholesterol drug Zocor, for example, became open to generic competition last year, costing the company billions of dollars in sales. Pfizer Inc. could lose patent protection on its Lipitor pill as early as 2010, opening the door to cheaper generic copies.

Such patent expirations that offer consumers big savings are a result of the 1984 Hatch-Waxman law, which largely covers products derived from chemicals, such as Zocor, Lipitor and the popular antidepressant Zoloft, to name a few. The life span of patents for chemically derived drugs is 20 years. Once such patents expire, generic copies can proliferate, with estimated savings to patients and taxpayers of about $10 billion a year, according to congressional studies.

Additional savings are forecast for 2008 if Congress passes a measure to allow competition from generic versions of biotech drugs. Such a move would open the door to prescription innovations for cancer, anemia and other treatments that are derived from human or animal cells and can cost tens of thousands of dollars a year.

In absence of such legislation, biotech companies would enjoy longer patent protection because there is no regulatory pathway within the Food and Drug Administration to bring generic versions of biotech drugs, known as biogenerics or biosimilars, to market.

"Quite simply, life-saving drugs are irrelevant if they are not affordable," said Christopher Begley, chairman and chief executive of Hospira Inc., a Lake Forest, Ill., maker of hospital products and specialized medication-delivery devices that is stymied in its ability to make generic versions of biotech drugs.

"There's no doubt it's time for Congress to pass legislation enabling the FDA to create an abbreviated biogenerics-approval pathway," Begley said. "With the progress made over the course of the past year, we're highly confident we'll see this happen in 2008." Begley's excitement comes because momentum is building to pass legislation in the coming election year.

The Senate Health, Education, Labor and Pensions Committee approved in June the Biologics Price Competition and Innovation Act of 2007, which would allow for biogenerics. The House is expected to take up similar legislation in early 2008.

The brand-name biotech industry has been fighting the proposed legislation, saying its medicines are made in a more complex manner because they are derived from humans, animals and other natural resources. Therefore, the biotech industry wants an application process to involve more testing of products than the abbreviated process common to drugs derived from chemicals.

Bruce Japsen writes for the Chicago Tribune.

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