Since their inception in the 1980s, biotech drugs based on natural proteins have come to mean the difference between life and death for millions of patients, treating diabetes, cancer, multiple sclerosis, heart attacks, and numerous genetic diseases. They boost the quality of life of millions more, people with conditions such as rheumatoid arthritis and Parkinson's disease. But such "large molecule" drugs also come with large price tags. Interferon beta, used to treat multiple sclerosis, runs $10,000 to $14,000 a year. Cancer treatments such as Herceptin can cost $20,000 to $30,000. And the prices of drugs for some rare diseases can top $200,000 annually. "People need these drugs for their survival," says Abbey Meyers, founder and president of the National Organization for Rare Disorders. "If they can't afford it, they're dead."

Patents on the first biotech drugs began expiring three years ago (see "Some Would-Be Biogenerics"), but the less-expensive generic versions that typically appear as soon as a drug loses patent protection have yet to hit the U.S. market. If you believe the arguments of pioneering biotech companies like Genentech and Amgen, the problem is the complexity of protein-based drugs -- or "biologics" -- which makes their duplication extraordinarily difficult. Without exact duplication, generics producers risk introducing drugs that may not work or could even harm patients. "Anything can be reverse-engineered and copied," Robert Garnick, Genentech's senior vice president for regulatory affairs, quality, and compliance, told a U.S. Food and Drug Administration panel in September. "However, some things are much safer [to copy] than others."