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Cheap, Generic 'Biologics' on the Way?

Congress Considers Allowing Companies to Make Low-Cost Copies of Drugs Like Insulin
WebMD Health News
Reviewed by Louise Chang, MD

March 8, 2007 -- High-cost drugs like insulin and new-generation rheumatoid arthritis medications could soon become a lot cheaper. That is, if Congress can succeed in finding a way to approve them as generics.

The issue could affect a wide range of high-priced drugs and vaccines that are called "biologics" because they’re produced by living cells under controlled conditions.

Insulin, a widely-prescribed biologic used by millions of people with diabetes, can cost patients $1,500 per year. Some newer biologics used to treat cancer can cost close to $50,000 per year. Rituxan, a biologic that targets immune cells and treats rheumatoid arthritis and non-Hodgkin's lymphoma, can cost more than $10,000 per treatment course.

But the FDA has no standard for proving lower-cost generic versions of biologics equivalent to the parent drugs. That has kept them off the U.S. market.

Consumer groups and businesses are now calling for a standard that would let generic companies gain government approval of copies once a brand-name biologic’s patent expires. Such a standard, they say, could save billions in health costs.

"This is our single fastest growing category of health costs, and the trend is simply not sustainable," Sid Banwart, a Caterpillar Inc. vice president, told a Senate hearing Thursday.

He said the company has spent $150 million on prescription benefits last year and that spending on biologics went up 45% since 2001.

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