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.
Generic drugs can cost half of their identical brand-name "parents," and insurers, employers, and patients credit them with savings billions in health costs each year. The copies are made by mimicking chemical active ingredients in a laboratory.
But biologics contain active molecules far larger and more complex than those in existing generics. Those molecules can't be precisely copied synthetically, and brand-name drugmakers closely guard information about the delicate and complicated biological reactions needed to produce them biologically.
Brand-name drugmakers maintain that the uncertainty makes generic biologics inherently unreliable and potentially unsafe. They want Congress to bar biologic generics from FDA rules that let drug companies make them without putting them through expensive human clinical studies.
"[Generic] biologics can be shown to be similar, but never identical, to an innovator," said Jay P. Siegel, MD, president of biotechnology, immunology, and oncology research and development at Johnson & Johnson, one of the world's largest manufacturers of biologics.
"You can't just take a molecule that has never been in people ... then all of the sudden market it to thousands of people. It's too risky," he said.
Generic Companies: We Can Do It
Generic manufacturers, meanwhile, say technology now allows them to backtrack from a biologic's ingredients and closely approximate its molecular structure. They accuse brand-name companies of stonewalling for fear of losing billions in revenues.
"The science is here and has been for over a decade," said Ajaz S. Hussain, vice president for biopharmaceutical development at Sandoz, a generic company owned by Novartis.
Complex as a 'Skyscraper'
A bill introduced last month would give the FDA the power for fast-track approval of generic biologics on a case-by-case basis, as long as companies can show they are essentially equivalent to the brand-name parent.
"The science supports an abbreviated pathway for [generic] biologics," said Sen. Hillary Rodham Clinton, D-N.Y., one of several sponsors of the bill. "We are finally at a place where we are debating how, not if."
Meanwhile, several key Republicans said the bill does not do enough to ensure the safety and effectiveness of highly complex biologic drugs.
Wyoming Sen. Mike Enzi, the senior Republican on the Senate Health, Education, Labor, and Pensions Committee, said if traditional drugs are as complex as a house, biologics were more akin to "a skyscraper."
"One girder out of place could cause the entire structure to fall," he said.