For Immediate Release	Contact: Alexandra Booze 202-467-5318
October 16, 2014

(Washington, D.C.) – Today, Citizens Against Government Waste (CAGW) released results from a poll conducted from September 30 through October 2, 2014 on the topic of biosimilars, a safe and less expensive alternative for patients who use biologics.  CAGW’s poll is a cross-section of 1,000 likely U.S. voters and shows there is growing support for getting biosimilars to the marketplace. 

One of the few positive elements of the 2010 Patient Protection and Affordable Care Act (PPACA) was the inclusion of the Biologics Price Competition and Innovation Act, which creates an abbreviated approval process for biological products that are highly similar, or biosimilar, to a biologic approved by the Food and Drug Administration (FDA).  A legal framework to approve biosimilars was established in Europe in 2003, and they have been used safely since the first medication was approved in 2006.  However, four years after the passage of PPACA, not a single biosimilar has been approved by the FDA.

“Biologics are a promising and vital new therapy for millions of Americans, but there has been a lot of talk about the high cost of these drugs.  The best way to drive down costs and encourage innovation is to begin approving biosimilars,” said CAGW President Tom Schatz.

CAGW’s poll shows that 78 percent of voters agree that healthcare costs are out of control and that FDA approval of biosimilars will encourage competition and lower prices.  When told that biosimilars provide the same benefit as biologics and can lower costs by as much as 40 percent, 88 percent of those polled agreed that biosimilars should be introduced into the marketplace.  In response to a question about whether the FDA has taken too long to create a pathway and needs to complete the process right away without more red tape, 77 percent of those polled agreed.

The FDA has created multiple stumbling blocks to fast-tracking these safe and affordable alternatives.  In many cases, the agency has failed to promulgate clear guidelines for manufacturers who want to bring them to the market.  Rules for when a biosmilar can be interchanged with its reference biologic are still pending.  The FDA has also delayed its decision as to whether biologics and their corresponding biosimilars should have the same international non-proprietary names (INNs).  In Europe, biosimilars share the same INNs as their reference products.  CAGW believes the same should occur in the U.S., since dissimilar names will cause unnecessary confusion for healthcare providers and patients.

“It is long past time for the FDA to fulfill its mandate to deliver a clear, regulatory pathway for bringing biosimilars to the marketplace and provide well-defined guidance, such as when a biosimilar is interchangeable with the reference product.  Four years is more than enough time for taxpayers and patients are waiting,” added Schatz.