Howard Dean on Biosimilars: At Least 12 Years Exclusivity

Legislation on innovative drugs is key to health reform

July 8, 2009
The Hill, Opinion
Howard Dean

More than 60 years after President Harry Truman called on Congress to provide Americans the “opportunity to achieve and enjoy good health” and “protection or security against the economic effects of sickness,” we are still fighting for healthcare reform.

Since Truman’s time, the health landscape in this country has changed dramatically. Diseases such as polio and tuberculosis are no longer the scourges they were. Advancements in biomedical research have led to treatments that have helped people with cancer, cystic fibrosis and a host of other diseases. In the 1950s, the cure rate for cancers was 33 percent, whereas today nearly two-thirds of people diagnosed with cancer live five years or more after their diagnosis.

As we move toward a universal healthcare system, most of the debate centers on big-picture issues such as how to craft and finance a public health insurance option. There is much less focus on smaller, but equally essential issues. One of these is patent reform. Another is maintaining America’s leading edge in research and innovation.

The Congress is now developing a regulatory pathway for the approval of biosimilars — medicines that are similar to, but not the same as, breakthrough biologics. Some inaccurately suggest that biosimilars are essentially generic versions of traditional pharmaceutical drugs. Biologics are actually much more complex than traditional drugs and cannot be copied using existing science. By expanding market competition, biosimilars can expand access to and reduce the cost of these cutting-edge drugs. But if the initial breakthroughs are not supported by adequate patent protection, innovation in America will die. And given the complexity of biologics, a properly constructed biosimilars pathway must provide necessary protections to ensure patient safety.

A commonsense and fair approach, similar to the process and timeline currently in place for generic versions of chemical-based medicines, would allow the original developer of the biologic to protect the proprietary data used to develop the medicine for at least 12 years. A shorter exclusivity period would prematurely rob biotech innovators of their intellectual property and destroy incentives to develop new cures. Most firms would be unable to recoup their investments in new medicines, which ordinarily top $1 billion and involve 15 years of research and development. If we discourage investment, we jeopardize the development of the next generation of breakthrough medicines and cures.

These principles are incorporated in biosimilars legislation sponsored by Reps. Anna Eshoo (D-Calif.), Jay Inslee (D-Wash.) and Joe Barton (R-Texas) in the House (H.R. 1548) and in The Biologics Price Competition and Innovation Act introduced by Sens. Edward Kennedy (D-Mass.) and Mike Enzi (R-Wyo.) in the last Congress. Both bills include a balanced approach that protects patient safety and encourages research that helps bring new, more advanced treatments — and even cures — to patients around the world. To encourage market competition, this should be combined with provisions that allow the patent life to begin running at the time of FDA approval, not at the time of application. Frivolous lawsuits over patents also should be eliminated at the end of patent life.

Today, too many diseases and disorders remain with no treatment or treatment with limited therapeutic benefit. With the right balance, we can set a path for biosimilars that maintains the highest standards for patient safety, lowers costs and increases access today while providing the necessary incentives for new therapies and cures tomorrow.