05.25.07

Burr Introduces “Affordable Biologics for Consumers Act of 2007”

Bill aimed at improving patients’ treatment options while encouraging innovation

U.S. Senator Richard Burr late yesterday introduced the Affordable Biologics for Consumers Act of 2007 with Senators Gregg and Coburn. The bill would establish standards for the approval of biosimilars - biologics that are similar to currently approved biologics. Biologics are products derived from living sources and include vaccines, blood, and gene therapy. Hundreds of such therapies, such as Herceptin and Enbrel, are used by patients throughout the United States today. Currently, there is no clear pathway for the Food and Drug Administration to approve biosimilars. The United States has a robust generics market for drugs, and many individuals are interested in creating a similar market for biologics.

"We must establish a clear approval process for this new class of biologics that ensures Americans will have access to additional safe and effective medicines," Burr said. "This bill will encourage development of life-saving therapies by clarifying and streamlining the approval process."

The bill establishes an open, public process for adopting rules governing the approval process for biosimilars at the Food and Drug Administration. At a minimum, biosimilar product-class rules will require companies to demonstrate the safety, purity, and potency of the product. The bill also provides for post-market safety monitoring to ensure that side effects are detected and reported. An expert panel of scientists in the therapeutic biologics field will advise the Food and Drug Administration on how to develop these new rules.