Generic biotech drugs backed

What do you call a drug that costs as much as $100,000 a year but doesn’t face competition?

If you’re a consumer footing the bill, you might call it an unfair monopoly. If you’re the biotechnology company selling the medication, it’s a money machine that needs to be protected at all costs.

All this could change soon. Democratic control of Congress -- gained through dramatic victories this week -- is expected to lead to legislation allowing generic versions of popular biotech drugs, lowering their costs.

Unlike with most pharmaceuticals produced by traditional drug companies, there is no federal regulatory system to approve generic versions of biotech drugs.

Patent laws are the same for biotech drugs as for regular ones, generally giving 20 years of exclusivity from the filing of an approval application. The biotech industry largely took off in the 1980s, so the earliest biotech medications such as insulin and human growth hormones are already off patent in the U.S. Over the next several years, the list is set to grow substantially.

Some lawmakers, such as Rep. Henry A. Waxman (D-Los Angeles) and Sen. Charles E. Schumer (D-N.Y.), have been trying to pass generic biotech legislation for years. One obstacle: The biotech industry has aggressively lobbied Congress to hold off, and many members have agreed until now.

With Democrats gaining power, however, the industry isn’t likely to stave off competition much longer.

A lot will depend on the influence of Waxman, chairman-elect of the House Committee on Government Reform, and others interested in seeing greater drug competition. In 1984, Waxman coauthored the law, known as the Hatch-Waxman Act, that allows the Food and Drug Administration to approve generic drugs.

But it applies only to traditional, chemically based medicines. Biotechnology drugs such as insulin and some cancer drugs are made using living organisms and manufactured inside bacteria or yeast cells in large bioreactors.

When the law passed, there weren’t many biotechnology drugs on the market. Since then, more than 300 have been approved, as the underlying science has improved markedly and manufacturers were lured by the hope that their products might never face competition.

In an interview Wednesday, Waxman said he planned to introduce legislation early next year that would set up a clear approval process for generic biologics.

“Biotech drugs promise life-saving benefits, but at a cost so high, many Americans cannot afford them,” he said. But he added that the “prospects for passing a generics biologics bill have improved significantly,” and the issue “is one of my highest priorities for the next Congress.”

Other lawmakers, including Sens. Hillary Rodham Clinton (D-N.Y.) and Orrin G. Hatch (R-Utah), have signaled interest in such legislation, although it’s unclear which, if any, bill they would support in the next term. It’s also unclear whether President Bush would sign such a bill.

Even in the rarefied world of the pharmaceutical industry, biotech drugs have grown into a gold-plated breed all their own. Although the sector failed to live up to its long-awaited promise of a “biotech revolution” for years, that’s changing. Medications such as Avastin, for colon cancer, and others for arthritis and AIDS have revolutionized the treatment of those diseases.

But it hasn’t been cheap. A several-month course of Genentech Inc.’s Avastin costs about $50,000. Enbrel, a drug for rheumatoid arthritis from Amgen Inc. and Wyeth Pharmaceuticals Inc., costs nearly $20,000 for a year’s supply.

Biotech’s ability to charge high prices is a major reason the sector is growing 16% a year, double the drug industry’s average. Sales in the U.S. are expected to top $50 billion by 2010 and account for an estimated 12% of the nation’s total drug bill.

Biotech companies say their products are too complicated for generic manufacturers to re-create, and the science isn’t advanced enough for safe and effective knockoffs.

The companies contend that generic makers should be required to conduct multiyear clinical trials before selling their own versions of the drugs, a requirement manufacturers couldn’t afford while selling generics at steep discounts.

Kelley Davenport, director of corporate communications for Thousand Oaks-based Amgen, said the main threat of biotech generics wouldn’t be to profits, but to patient safety.

“Even small differences in these products can cause differences in effectiveness and unexpected side effects, especially in the many seriously ill patients who rely on these medications,” she said.

Generic drug manufacturers disagree, countering that the science behind biologics is no longer as complex as top-line drug makers make it out to be. Scientists, they say, are making advances all the time. Several companies say they could create nearly identical copies of several high-priced biotech drugs immediately if they had the regulatory approval.

“My personal view is that biotechnology is more complicated than traditional pharmaceuticals, but we have the skills and knowledge necessary to understand and deal with it accordingly,” said Bruce Downey, chairman of Barr Laboratories Inc., a large generic manufacturer.

Experts believe the reality is somewhere in between. Even under the best circumstances, a generic version of a biotech drug will never be exactly the same as the original, as is the case with chemical drugs.

Still, Bryan Liang, executive director of the Institute of Health Law Studies at California Western School of Law in San Diego and a medical doctor, says it’s possible for manufacturers to re-create simpler and older biotech drugs such as insulin and human growth hormone fairly easily. That’s because they’re made up of a relatively small number of proteins and molecules that scientists have already mapped out and can safely mimic.

With more complicated medicines, however, that probably isn’t possible just yet. Some biotech drugs, such as monoclonal antibodies that treat cancer, are so complex and packed with proteins that not even their originators entirely know how they work. Trying to re-create them and sell them to the public without doing extensive safety trials could be disastrous.

Amgen, the world’s largest biotech company, knows well how dangerous that can be. In the late 1990s, the company licensed one of its biggest-selling products, the dialysis drug Epogen, to Johnson & Johnson, which manufactures and sells a nearly identical version of the drug overseas called Eprex.

Soon after, several patients on the drug developed a rare condition known as red cell aplasia, in which the body’s germ-fighting defenses stopped working. Those affected have to get regular blood transfusions, sometimes for the rest of the lives.

Some companies such as Sandoz Inc., another large generic manufacturer, are going ahead without congressional approval. In April, a federal judge ordered the FDA to act on a long-delayed Sandoz application for a generic version of a human growth hormone. For a technical reason, the case doesn’t affect most biotech drugs, but many still saw it as a watershed moment for the industry.

Waxman said he would probably reintroduce a bill he put forth this fall that never got a hearing. The Access to Life-Saving Medicines Act would establish a flexible approval process for biologics that would take into consideration that not all of them are alike.

An applicant would have to establish proof that a generic was similar enough to the original that it didn’t require more extensive human trials. If it couldn’t, the company would have to do so.

Such considerations are why no one can say for certain how much cheaper a biotech replica would be. If a manufacturer didn’t have to conduct trials, it could knock as much off the sticker price as with regular generics -- about 20% to 50%.

Even if Congress passes the bill, which calls for approval processes similar to but potentially less rigorous than what the European Union and Australia have established in recent years, it could still be many years before generic companies are able to get the FDA to scrutinize and approve cheaper products.

Many experts also predict brand-name companies are likely to spend years in court over patent disputes, which are common with all generics.

But at least it would be something, advocates say, that could eventually save consumers a significant amount of money.

“Safety, of course, has to be the No. 1 concern,” said Eric Pomerantz, vice president and general counsel for Sandoz. “But there are ways to do this safely and save people money at the same time.

“Remember, these were the same kinds of things the industry was saying in 1984. And that [law] is one of the best things Congress ever did for drug prices.”

daniel.costello@latimes.com

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High stakes

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Here are some biopharmaceuticals that are susceptible to generic

competition in the U.S. in the upcoming years:

*--* Sales* Brand name Use Lab (In millions) Epogen/Procr Anemia Amgen $5,779 it Avonex Multiple Biogen 1,543 sclerosis Neupogen Cancer Amgen 1,216 Humulin Insulin Eli Lilly 1,005 Cerezyme Gaucher’s Genzyme 932 disease Humatrope Growth Eli Lilly 414 hormone Novoli Insulin Novo Nordisk 404 Nutropin and Protropin Growth hormone Genentech 349 Intron A Hepatitis Schering- 287 Plough Activase Stroke Genentech 98

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*All sales are worldwide except Novolin’s, which are only for U.S.

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Sources: Generic Pharmaceutical Assn., Times research