Drug Competition In Peril

Legislation Would Stymie Generic Versions Of Expensive Biologic Medications

August 28, 2009|By Jane Andrews

When Congress members return in two weeks, they will be discussing a health care reform bill that attempts to provide care for the uninsured and to address our skyrocketing health care costs.

Simultaneously, however, the House and Senate are considering proposals that would prevent lower-cost pharmaceuticals from coming to market by regulating generic versions of biologics known as follow-on biologics or "biosimilars."

Biologics, protein-based pharmaceuticals produced within living cells, include all vaccines, most new cancer agents, and critical arthritis and psoriasis drugs. According to the Federal Trade Commission, they represent 14 percent of the U.S. pharmaceutical market and are its fastest-growing component.

They are also among the most expensive drugs sold in the U.S. For example, the anti-cancer agent Avastin costs upward of $50,000, and the popular anti-rheumatoid arthritis drug Enbrel sells for $15,000-$20,000 a year. Americans spent $40.3 billion on biologics in 2007.

Currently, there is no mechanism for approving generic forms of these drugs. The proposals before Congress are an attempt to create a pathway for allowing these biosimilars into the market. But the legislation favors pharmaceutical companies and hurts patients by offering brand-name companies 12 years of market exclusivity before generics can come to market. Traditional chemical drugs receive five years of market exclusivity before generics may be produced.

Even worse, current proposals permit brand-name companies to make minor modifications to their products at the end of a 12-year market monopoly, and then receive another 12 years of exclusivity. This process would yield a perpetual monopoly. The current legislation would virtually eliminate the possibility of generic competition.

The Federal Trade Commission released a fact-finding report in June estimating that follow-on biologics would take eight to 10 years to develop and cost $100 million to $200 million. Due to high production costs and slow market acquisition, the FTC recommended zero years of market exclusivity for biologics, a far cry from the currently proposed 12 years.

Not only do the policies surrounding biologics have implications for health care in the United States, but keeping generic biologics out of the market would also make new vaccines prohibitively expensive for developing countries. Given that poor countries are dependent on generics even for inexpensive medications like ibuprofen and acetaminophen, flawed biosimilars legislation would make expensive, lifesaving cancer and autoimmune medications inaccessible.

As a student of medicine and public health at the Johns Hopkins University, I am amazed that the Association of American Universities (AAU), a consortium of 62 leading public and private research universities, has publicly supported a proposal for regulation of biosimilars that eliminates the possibility of generic competition. While virtually all other consumer groups publicly opposed the proposal in Congress, the AAU appears to be supporting a policy that would solely benefit pharmaceutical companies, cost the United States billions of dollars, and reach beyond our borders to restrict access to lifesaving medicines to people in developing countries.

In the United States, our families and neighbors struggle to obtain costly drugs for rheumatoid arthritis, cancer and multiple sclerosis. This is a sad state of affairs for a country that spends more per capita on health than anywhere else in the world. In poorer countries, biologics produced in the U.S. are a pipe dream.

Maryland Sen. Barbara A. Mikulski and Rep. John P. Sarbanes of the state's 3rd Congressional District both sit on committees influential in crafting legislation for biosimilars. Before Congress went to recess, Representative Sarbanes admirably voted against the current proposal, while Senator Mikulski openly supported the bill (and was praised by the Biotechnology Industry Organization).

At the end of September, we will either be presented with a bill that promotes generics and thus increased access to medications for patients, or a bill that prevents generics from coming to market and will mean higher-priced medications for patients in our future. Senator Mikulski and Representative Sarbanes: Do not let the pharmaceutical industry fool you. The rest of us are not sold.

Jane Andrews is a medical student and public health student at the Johns Hopkins University and a member of Universities Allied for Essential Medicines. Her e-mail is jandrews@jhsph.edu.

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