WASHINGTON, DC – U.S. Senator Pat Roberts (R-KS) today joined a bipartisan group of Senators to support a bill allowing the Food and Drug Administration (FDA) to approve low-cost versions of biological drugs, which could then bring additional dollars into federal health programs. The bill was unanimously approved by the Senate Health, Education, Labor and Pensions (HELP) Committee and now goes to the full Senate for debate and a vote.

Biologics are drugs made from living material, which include products such as insulin and Epogen, unlike traditional drugs which are made from chemical compounds. These low-cost products - which will be known as "biosimilars" - currently cannot be approved by the FDA like generic drugs can be approved for traditional drugs. This bill creates the necessary pathway for the approval of these affordable products while still ensuring groundbreaking and innovative research will continue.

"I applaud the HELP Committee’s passage of this bill to chart the course to bring more affordable drugs to the market," Senator Roberts said. "The health savings from this bill can help fund vital programs like health preparedness and nursing programs I have long supported."

The Biologics Price Competition and Innovation Act of 2007, S. 1695, introduced by Senators Ted Kennedy (D-MA), Mike Enzi (R-WY), Hillary Clinton (D-NY) and Orrin Hatch (R-UT), creates a pathway to approve safe biosimilar and interchangeable biological products by the FDA after the original biologic drug has been on the market for twelve years. For safety approval, the biosimilar must produce the same clinical result as the brand name product and present no additional drug safety risk if a patient should switch between products.

One provision of the bill allows the Department of Treasury to determine the savings to the federal government from the approval of these biosimilars and then put those savings into a "Biological Product Savings Fund" at the Department of Health and Human Services (HHS). HHS can use these funds for any programs that fall under the Public Health Service Act, which include nursing workforce and development programs, state grants for trauma care, health professions programs and medical research at the National Institutes of Health (NIH).

"I support this new system to create more affordable biological products while ensuring product safety and product innovation," Senator Roberts said. "These life-saving products are critical for our health, but they are often very expensive. This is why it is so important to offer a cheaper alternative of these drugs for consumers who rely on these products each and every day."

Senator Roberts is a senior member of the Senate Committee on Health, Education, Labor and Pensions and the Senate Committee on Finance.