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Law Emerging in US for Generic Versions of Biotech Medicine

The US might be a capitalist-friendly land. But there too strident voices are being raised in favor of consumers. As a result legislators are now moving// to ensure availability of lower-cost copies of biotechnology drugs that now cost tens or hundreds of thousands of dollars a year.

Generics are now allowed only for traditional, chemical compounds whose patents have expired. You can't get them for complex biological drugs such as hormones or antibodies used in cancer treatments. Some of the world's most potent and popular medicines fall into this biotech basket, and existing federal laws prevent them from going generic.

Conventional drugs are synthesized by putting atoms together from basic chemicals and are often in pill form.

Biotech drugs, also known as biologic products, are typically proteins made by modifying the DNA of bacteria, yeast or mammal cells, and they are often given by injection or infusion.

A legislation is being hammered to enable the Food and Drug Administration (FDA) to approve of generic version of biotech drugs without trials.

Biotech medicines are the fastest-growing category of health spending, with sales of $40 billion last year, up 20 percent from 2005, according to IMS Health, a market research company. More than 400 biotech products are in the pipeline, for more than 100 diseases, including cancer, AIDS, diabetes and Alzheimer’s.

But then the bio-tech drugs are prohibitively expensive. A year's worth of Genzyme's (DNA) Cerezyme, for a rare ailment called Gaucher's disease, can top $200,000. Genentech's cancer drug Avastin costs as much as $100,000 per year. That places a huge burden on companies who cover the treatments in their health plans and on consumers.

Consumer groups, employers and insurers are working in tandem with Democrats who have taken control of the US Congress this year on the issue. That is the only way to hold down health costs, they say.
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