For patients and families alike, a diagnosis is a terrifying experience. Husbands feel powerless. Future plans that were once certain are shelved. Children start asking questions that don’t have easy answers. New doctors and unfamiliar medical terms become a daily reality. Anger and desperation often set in.
Until recently, the only real treatment for women with HER2+ breast cancer, a particularly aggressive form of the disease that afflicts about one in five breast cancer patients, was surgery and chemotherapy.
A novel treatment called Herceptin, though, is offering hope. When combined with chemotherapy, studies indicate that it lowers the risk of breast cancer relapse by about 50 percent. And a new bill in Washington could ensure that treatments like Herceptin continue to be developed.
Herceptin is a member of a new generation of pharmaceutical drugs known as biologics. Made from live tissue and cells, biologics use the human body’s own immune system to attack cancer cells while leaving healthy cells untouched.
The history of Herceptin began in the 1970s, when scientists found that certain genes were present in malignant breast cancer cells but absent in healthy cells. This eventually led to the discovery of the protein receptors that fuel abnormal cell division. By the 1980s, research was aimed at disabling these receptors and starving cancer cells.
Soon enough, scientists turned their research into a treatment — today called Herceptin — that could combat breast cancer by disrupting cancer cell growth. In 1998, Herceptin was approved by the FDA.
As one might expect, Herceptin is quite expensive — a treatment course costs around $70,000 annually. Other biologics carry similarly steep price tags. To help make these drugs more affordable, policymakers are considering a bill that would allow for the approval and sale of “biosimilars,” which are copycat versions of biologic drugs.
The legislation is called the Pathway for Biosimilars Act. Fortunately, it recognizes that the high price of biologic drugs reflects the cost of producing these medicines and the risk involved.
The typical biologic therapy costs nearly $1.5 billion to research, develop, and bring to market. A biologic manufacturing facility can cost as much as $450 million to build. And less than one-third of biologics that enter clinical trials ever get approved for sale and use by patients.
Despite these obstacles, investors continue to pour money into medical research firms, because they know that blockbuster drugs like Herceptin — as rare as they are — will recoup their upfront costs and turn a profit.
Of course, this all depends on strong intellectual property protections. Without the exclusive right to sell their final product, researchers would have effectively zero chance of making back their investment in sales. This holds true for virtually all medical research.
Because biologics are grown in living cells — and not isolated or synthesized, like conventional drugs — biologics patents are extremely susceptible to legal challenges. Consequently, biologics need additional intellectual property safeguards. Without such safeguards, many firms may decide the risk is not worth the reward.
Luckily, the Pathway for Biosimilars Act calls for a 12-year period of “data exclusivity” for new biologics. Data exclusivity allows companies to keep their proprietary research data on new biologics private for a pre-specified period of time. After that period of time expires, competing companies can access that research and use it to create biosimilars. Academic research suggests that 12 years is just about enough time for biologic firms to break even. According to Duke University professor Henry Grabowski, the ideal time frame for data exclusivity is 13 to 16 years.
Passing this important legislation will ensure that researchers can continue to develop drugs like Herceptin. It will also help expand access to today’s most-advanced medical treatments and allow for the development of new biologics.
Sally C. Pipes is President and CEO of the Pacific Research Institute. Her latest book is The Top Ten Myths of American Health Care.