Generic biotech drugs urged

The Baltimore Sun

WASHINGTON -- Marta Ockuly was a week away from gaining health insurance at her new job in Sarasota, Fla., when she was diagnosed with a devastating form of cancer. She quickly began chemotherapy, which drove her leukemia into remission but weakened her body's immune system so much that she required shots of a new kind of drug, made using biotechnology.

Ockuly credits the biotech drug, Neupogen, with helping save her life four years ago, but wishes there had been a generic alternative available for less than the $1,000-a-shot she says hers cost. The high cost of drugs and treatment drove Ockuly to bankruptcy. "It pretty much would have wiped anybody out," said Ockuly, who now counsels cancer patients for the Wellness Community, an international support group.

The high cost of health care is back at the top of Washington's agenda. While President Bush in his State of the Union speech this week recommended changing the tax code to curb spending on health care, Democrats are expected to propose paving the way for cheaper, generic versions of biotech drugs.

Biotech drugs are the fastest-growing category of medicines, treating ailments from heart disease to rheumatoid arthritis.

Biotech drugs are more complicated to make than traditional medicines, so they tend to cost more, sometimes tens of thousands of dollars for a year's prescription. Among the most popular are insulin and human growth hormone.

Democrats argue that generic versions would slash these prices, just as the 23-year-old federal law that fostered production of copies of traditional drugs has done.

"Legislation is essential to keep the new generation of life-saving drugs affordable," Rep. Henry A. Waxman, a California Democrat, said through a spokeswoman. Waxman, who sponsored a law with Utah Republican Sen. Orrin G. Hatch governing generic versions of traditional drugs, called passage of a similar bill for biotech drugs "one of my highest legislative priorities."

But powerful pharmaceutical companies argue that the government would be moving too quickly if it authorized sales of generic biotech drugs.

James C. Greenwood, president of the Biotechnology Industry Organization, is telling lawmakers that the legislation would deter drug makers from developing innovative biotech drugs by removing financial incentives. Greenwood also warns that the science hasn't advanced far enough to copy biotech drugs safely.

In 1984, Congress gave the Food and Drug Administration the authority to approve generic drugs for sale without demanding the same costly studies of health effects required for the originals. That allowed manufacturers to market knockoffs faster and more cheaply.

The FDA says it needs similar authorization before it gives copies of biotech drugs speedy reviews. Deputy Commissioner Janet Woodcock says the process would have to be different from the way traditional generic drugs are reviewed. That's because science hasn't advanced far enough for the agency to establish that the biotech copies are identical to the originals - only to say they are similar.

That's why the FDA calls imitations of biotech drugs "follow-ons," not generics. Likewise, the agency wouldn't allow pharmacists to freely substitute follow-on biotech drugs for originals, as they can do with traditional medicines. A doctor would have to specifically request the follow-on, unless the generic drug makers prove through studies that the original and its imitation are the same.

"We will do what is scientifically valid, and that advances over time," Woodcock said. Right now, she adds, science has only reached the point at which the FDA could safely rule on the follow-ons of simpler biotech drugs.

Traditional drugs are simple chemicals formed when small molecules combine, like a few beads that make up a necklace. Biotech drugs are far more complex, a necklace of many beads that fold into various shapes. They can be created naturally but are usually made through recombinant DNA technology.

Since emerging in the early 1980s, their use has soared. More than 150 are on the market. Sales grew to $33 billion in 2005, a 17 percent increase over the previous year, according to IMS Health, which provides information on the pharmaceutical market. Sales of the drugs are expected to exceed $50 billion by 2010.

Given the sums involved, generic drug makers have begun developing follow-on versions even without a speedy approval process in place. Patents on biotech drugs are beginning to expire, which would give generic drug makers the legal clearance to sell them if they receive the FDA's go-ahead. European countries have established a process, and the generic companies predict Congress will take action.

"It's a matter of when it's going to come, not if it will come," said Carol Cox, a spokeswoman for Barr Laboratories, of Woodcliff Lake, N.J., which is developing versions of Neupogen and 10 other biotech drugs.

Supporters predict substantial savings. Omnitrope, a copycat of a human growth hormone that the FDA approved last year as a traditional drug after its maker sued the agency, sells for 20 percent less than the original, says Kathleen Jaeger, president of the Generic Pharmaceutical Association, a trade group lobbying for the legislation.

Also last year, the governors of Kansas, Minnesota, Vermont and Wisconsin urged the FDA to take steps toward approving generic insulin and human growth hormone, saying Americans would save hundreds of millions of dollars on the $1.9 billion they spend each year on the two drugs.

The Pharmaceutical Care Management Association estimates that follow-on biotech drugs would cost 25 percent to 40 percent less than branded products; the group, which represents firms that manage health benefits for employers, government agencies and unions, says Medicare's Part B drug program would save $14 billion over 10 years.

"I'm sure the government has other holes to put the money in than to pay for drugs," said Gregory Volinsky, who says he is receiving $2,975 shots of the biotech drug Neulasta, a longer-lasting version of Neupogen, through Medicare Part D.

Volinsky, a 69-year-old resident of Timonium, has had three Neulasta shots and will have at least one more. It is helping his immune system recover from chemotherapy treatments, Volinsky says, but he wishes there was a cheaper, generic option, as there is for the heart medications he takes.

Yet critics note that prices won't drop as much as they have for traditional medicines - which fall as much as 80 percent, according to the Congressional Budget Office - because biotech drugs cost much more to make. What's more, they emphasize that science hasn't advanced enough to make the kinds of exact replicas Americans normally associate with generics.

"Even small differences in products can cause differences in effectiveness and can cause unexpected side effects, some of which can be very serious," said Kelley Davenport, a spokeswoman for Amgen, of Thousand Oaks, Calif., which makes Neupogen and Neulasta. Amgen disputed the costs given for the two drugs, saying the wholesale price for the smallest dose of Neupogen is $213 and $2,735 for Neulasta. The two drugs had $772 million in U.S. sales in last year's third quarter.

On his lobbying trips to the Capitol, Greenwood, president of the biotechnology trade group, compares a plastic model of simple aspirin with a video displaying the complex, three-dimensional image of a biotech drug, Epogen. "Just to give members a sense of the difference," Greenwood said.

Yet the legislation enjoys unusually broad support, in part because of its potential to cut health care costs for businesses as well as for individuals.

"This won't have the ideological edge that some other health care issues will have because the business community will be very supportive," said Mark Merritt, president of the Pharmaceutical Care Management Association.

jonathan.rockoff@baltsun.com

About biotech drugs

Biotech medicines are a class of drugs that are more complicated in structure than traditional drugs and often made through genetic engineering.

What do they do? Biotech drugs treat many of the same diseases that traditional drugs do, such as heart disease and cancer.

How effective are they? More than 150 are on sale, and the FDA has judged them safe and effective. Insulin and human growth hormone are widely used examples.

How much do they cost? Biotech drugs tend to cost more than traditional drugs. A year's supply of Enbrel, which treats rheumatoid arthritis, costs almost $20,000. A several-month course of the anti-cancer drug Avastin costs $50,000.

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