"CHICAGO -- Generic drug companies are laying the groundwork for copycat versions of expensive biotech drugs and hoping that regulators see their cheaper versions as key in the battle against soaring health-care costs. Bioengineered drugs made from complex proteins generally enjoy unlimited monopolies because no regulatory pathway exists in the key U.S. market for generic companies to copy them.
Unlike standard synthetic pharmaceuticals, which typically come in pill form, most biotech drugs are laboratory-altered forms of proteins, making them much more complicated to copy. So when Eli Lilly and Co.'s Prozac patent ran out several years ago, generics flooded the market, Lilly's profits plunged and consumers got a price break on the best-selling antidepressant.
But no generic firm, under current U.S. regulations, can use the same process to copy Insulin, the gold standard genetically-altered hormone used to control blood sugar in diabetics, a treatment first discovered in the 1920s. A steady stream of biotech drugs are hitting the market to serve an aging population, and their costs dwarf the price of conventional pharmaceuticals.
For example, Genentech Inc.'s Avastin for colon cancer costs insurers and patients thousands of dollars a month. A majority stake in the company is held by Swiss drugmaker Roche Holding AG .
"When you look at the numbers, you see an explosion in the field, and we believe this represents a significant opportunity" for generic versions of biotech drugs, said George Barrett, North America president for Teva Pharmaceutical Industries Ltd. the world's biggest stand-alone generic drug maker.
Israel-based Teva is "actively engaged in the development of products for biotech," he said.
Another generic player, Barr Pharmaceuticals Inc. made a deal in March with Croatian drugmaker PLIVA to make a generic version of Amgen Inc.'s Neupogen, a biotech drug used to reduce chemotherapy-related infections.
Cost Saver: Generics are generally chemical copies of branded drugs with expired patents. Use has flourished in recent years, especially in the U.S. as employers and governments struggle with double-digit increases in medical costs.
Generics represent half of the drugs dispensed in the U.S., but just roughly 12 percent of every dollar spent on health care, according to the generics industry group.
At the same time, spending by employers and governments on treatments for cancer, a major therapeutic area for biotech, is increasing at twice the speed of traditional pharmaceuticals, according to pharmacy benefits manager Medco Health Solutions Inc.
The rapidly escalating biotech costs have spurred U.S. employers to lobby in Washington for a way to get FDA approval for the drugs.
Biotech drugs account for about 10 to 15 percent of health-care spending, which is rising 20 percent annually at DaimlerChrysler, the world's fifth biggest automaker.
"We support some type of guidance on how generics can be manufactured for bioengineered drugs," said Roger Panella, a senior health benefits manager at DaimlerChrysler.
The FDA, for its part, is working on a guidance document for the generics industry to follow, but it has been delayed several times. Some believe the FDA would like Congress to pass legislation authorizing it to do that.
"At Teva, we believe the FDA has that right today," Barrett said, echoing the industry's position.
"FDA Blinked": The FDA recently rejected a bid by Swiss drugmaker Novartis AG's generic unit Sandoz to make a generic form of human growth hormone, a synthetic hormone used for children with growth-stunting disease.
"The FDA blinked and wrote them a letter saying there are still scientific and legal issues," said Ira Loss, a health-care policy expert at Washington Analysis.
Europe looks likely to be the first major market for generic biotech drugs. The European Medicines Agency has guidelines for biogeneric products and could approve a product as early as this year.
Biologics contain large molecules, whose exact structure can vary according to manufacturing processes, which, the brand name industry argues, would make the products inferior.
For the U.S. market, though, the generic firms have several years to wait. Because most of the high-priced biotechs are not losing their patents in the immediate future, the cost explosion is still a few years off, analysts said.
"They are not at the precipice yet" in terms of cost burden, Loss said."
Source: Kim Dixon: Generic firms lay groundwork for biotech drugs. Reuters (21 Mat 2005) [FullText]