Coalition for Safe and Innovative Medicine

September 25, 2009
Connecticut Record Journal
By Jim Greenwood

For too long, the health care debate has focused on issues that divide the political parties, undermining meaningful reform. Many lawmakers have, however, been able to find common ground on one issue in this massive debate: the approval of biosimilars. Biosimilars, often erroneously referred to as biogenerics, are medicines that are similar to, but not the same as breakthrough biologic medicines.

Biologics represent the cutting edge of medicine, providing advanced therapies and drugs that are saving and extending the lives of patients living with debilitating diseases including cancer, Multiple Sclerosis and HIV/AIDS. Continued advancements hold the promise of improved medicines and, one day, cures. By allowing biosimilars to enter the marketplace, Congress can increase patient access to life-saving medicines, reduce costs and provide a foundation for continued biomedical innovation.

It’s easy to assume that continued biomedical advancement is a given — that the hard work and dedication of our scientists will move research forward, unaffected by the health care reform debate taking place. Thoughtful lawmakers know otherwise. That’s why we saw such strong bipartisan support in both Houses of Congress for language included in health care reform bills that would create a pathway for Food and Drug Administration (FDA) approval of biosimilars. Both provisions strike the right balance among increasing access, ensuring patient safety and promoting continued biomedical breakthroughs.

These provisions first and foremost ensure that biosimilars are safe. Biologics are extraordinarily complex medicines made from living organisms, and as the FDA has noted, biologics cannot be copied exactly. Therefore, it is critical that the FDA base its approval of biosimilars on the same rigorous standards of safety, purity and potency it applies to all other biologics.

These measures also balance the need for continued innovation with provisions aimed at expanding the robust competition already in place. There are currently hundreds of biotech companies competing against one another in a race to find a cure for cancer, heart disease and other diseases and disabilities. Allowing biosimilars to enter the marketplace not only will increase this vibrant competition, it will expand access to the life-saving medicines available today and ones yet to come.

Meanwhile, the pathway supported by bipartisan majorities in key committees in the House and Senate includes incentives to continue innovating. Developing a new treatment or therapy can cost upwards of one billion dollars and require a decade or more of research, development and testing. The pathway adopted by the committees would protect the intellectual property of the innovators and maintain the incentives necessary to secure the investment that leads to new therapies and cures.

It’s good to know that when patients are on the line, Republicans and Democrats were able to put their differences aside, and move well-crafted, balanced policy forward.

As both the House and the Senate continue their debate on health care reform, I call on Connecticut’s lawmakers to ensure that this biosimilars language is included in the final legislation. Patients and their families deserve a bill that promises increased access to safe, life-saving medicines and ensures the continued development of new therapies and cures.