Almost a quarter-century ago, the U.S. Congress reached a bipartisan agreement to open up the pharmaceutical industry to generic competition. This step was a tremendous victory for patients who bene fited from lower prices amid continued innovation.

Today Congress faces a similar issue. This time it concerns a new class of drugs, called biologics, that hardly existed back in the mid-1980s but that are increasingly important to patient health. They are genetically engineered protein molecules used to treat diabetes, arthritis, cancer, and other ailments.

A market of more than $10 billion of biologics is due to go off patent by 2011 with an additional $9 billion to $10 billion coming off patent between 2012 and 2015. Unless Congress allows monopoly-busting competition by creating a regulatory pathway for generic versions of these medicines from other manufacturers, the costs can be expected to remain high for the majority of patients who need them.

The stakes for patients and their caregivers are significant. Biologic medicines are complex and expensive to develop. As such, they can cost 20 times more than traditional drugs, with some costing up to $200,000 a year. Biologic drugs are responsible for the top drug expenditures under the Medicare Part B program. By 2009, sales are estimated to reach $90 billion.

These costs reflect the high expenditures for research and development that go into creating these medicines,the complexity of their manufacture, the enormous patient benefit, and the need for innovators to make a reasonable profit. It also reflects that they are sold under monopoly conditions that permit prices to remain high.

Biotech-based drugs account for around 10 percent of the current pharmaceutical market, and the biologics sector is growing faster than the traditional drug market given the enormous potential to help patients.

Patients, senior groups, employers, and health care providers are asking Washington for help in the face of these rising costs. Bringing competition to the current de facto monopoly will not only lower costs, but also bring competition and advancement to one of our most innovative industries.

Critics of the push for biogenerics argue that due to the complexity of the drugs, the cost savings will be smaller than those for traditional drugs that were opened to competition. This may be true. But a recent study commissioned by my company, Insmed, found potential savings of more than $370 billion over the next two decades alone. Patients with access to products created in a competitive market should be permitted to determine if they want those savings. Each dollar saved is a dollar they can use for other medical needs.

The critics assert that the savings aren't worth the risk. They say producing biogeneric drugs is tricky and might not yield the same kinds of results for patients.

It's worth noting that similar arguments were made in 1984 when Congress first considered generic competition. And yet competition for generics has been an enormous success. No one wishes to go back to a world before generic medicines were available.

America's competitive edge is at stake. Europe is already ahead of the U.S., having established an approval process for biogenerics in 2006, expanding patient access, opening new markets, and attracting high-paying technical jobs.

A new era of innovation in biotechnology holds promise for patients. The science and technology behind making generic biologics has reached a level of sophistication to make this endeavor entirely possible. Our firm is made up of scientists and engineers who have been making these original biologics for years. We are ready to produce these medicines at our state-of-the-art, FDA-approved facilities the moment Washington gives permission.

Respect for the intellectual property rights of companies is a serious and important issue. We recognize that, particularly since we manufacture our own innovator medicines, including a promising treatment used for muscular dystrophy and other diseases. But companies should not be protected from competition forever. Indeed, competition is healthy for the biotechnology sector, as it is for all other industries in the free enterprise system.

Presidential candidates from both parties are stumping hard on the campaign trail discussing ideas about how to fix the U.S. health care system, particularly the rising costs of care. Both sides should be able to agree that ushering in an era of generic biologic drugs will help put downward pressure on health care costs. This was a prudent bipartisan step back in 1984. It would be a prudent step once again.
Dr. Geoffrey Allan is the CEO of Insmed Inc., a biopharmaceutical company with facilities in Richmond and Boulder, Colo. Contact him at (804) 565-3000.