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Amid the furor surrounding health care reform, a quiet but intense struggle is being waged over a cutting-edge form of medicine that is revolutionizing treatments for cancer, arthritis, multiple sclerosis and other conditions.

At issue are biotechnology drugs—commonly called biologics—that are complex products made from living organisms.

Although these drugs can sustain and improve the quality of life for many patients, they are expensive—sometimes costing $100,000 or more annually. Insurance coverage varies widely, and as a result, many patients can’t afford them.

No generic alternatives to biologics

Currently, there are no generic alternatives—often called biosimilars—to biologics in the United States. The Food and Drug Administration lacks authority to approve them because Congress has not addressed the issue.

As part of the health reform debate, Congress is considering how long biologics should be protected from generic competition. Traditional drugs are now given up to eight years of exclusivity before generics are allowed on the market.

Committees in the House and Senate have adopted a 12-year exemption period, but the legislation is tied up with the larger health care package.

Advocacy groups such as AARP, employers and insurers want a shorter exclusivity period, arguing that the sooner biosimilar drugs are allowed, the greater the savings for consumers and the government, which spent $13 billion on biologics through Medicare in 2007. They point to the widespread use of generic drugs, which are chemically similar to brand-name drugs, as evidence of potential savings.

Generic medication savings

Generic medications saved an estimated $121 billion in 2008, according to the Generic Pharmaceutical Association.

In North Carolina, 52 percent of residents’ prescriptions were filled with generics in 2005, the latest year for which statistics were available, according to a recent AARP report. Industry officials say that figure is undoubtedly higher now. The national generics average in 2008 was about 70 percent of prescriptions.

Prescriptions for biologics are certain to grow in the coming years.

Biologics now represent 17 percent of prescription drug spending, but just 2 percent of the prescriptions filled, said Steve Miller, M.D., chief medical officer for Express Scripts, a pharmacy benefit management company.

A matter of exclusivity

Biosimilars would produce estimated savings to the federal government of up to $12 billion over the first 10 years after legislation took effect, the nonpartisan Congressional Budget Office reported. But greater savings would result if the 12-year exclusivity window were reduced, the CBO said.

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