Statement from Ralph G. Neas, President and CEO, Generic Pharmaceutical Association, on the Front Page New York Times Story Regarding the Pre-emptive Strikes of Amgen/Genentech to Restrict Access

PRESS RELEASE

WASHINGTON, DC (JANUARY 29, 2013) - Today's story shines a light on what essentially is a pre-emptive strike by Amgen and Genentech designed to choke the flow of safe and affordable life-saving biologic medicines to patients even before these products have been approved by the Food and Drug and Administration (FDA). This is unfortunate because it puts profits ahead of the patients who need these treatments but many times cannot get them because of their prohibitively high cost.

The efforts highlighted in the Times story are doubly worrying for state legislators because not only will they slow availability of safe, effective and more affordable therapies to patients, but they also will dramatically decrease the much-needed cost savings that biosimilars will provide. At a time when legislators are desperately seeking ways to keep their state fiscally sound, these bills will encourage needless and wasteful spending on name brand therapies even after FDA-approved lower cost biosimilar products become available.

While in the guise of supporting biosimilar efforts, Amgen and Genentech are making every effort to limit consumer and patient access to safe and effective biosimilars in the future.

Biosimilar medicines, which are less costly versions of brand-name biologics, have been used safely in Europe for nearly seven years. However, these affordable treatments are not yet available in the U.S. But under new federal laws, the FDA now is developing regulations that will allow for the approval and use of biosimilars here at home. Make no mistake: patient safety is paramount both for the FDA and for the companies that will make these medicines. In fact, many of the companies who are working to develop biosimilars are the same companies now making brand name biologics.

As the Times story correctly notes, efforts by brand companies to erect barriers to competition from lower cost generic versions of their drugs have been going on for decades. But as is true with traditional prescription drugs, competition from safe, effective and more affordable biosimilars will, in the coming years, provide patients the savings they need while delivering the lifesaving therapy they depend upon.

According to an analysis by IMS Health published August 2, 2012, generic medicines saved the U.S. health care system more than $1 trillion over the past decade, $192 billion in 2011 alone. We are confident that the use of safe and effective biosimilars will achieve similar savings.