Statement from Ralph G. Neas, President and CEO, Generic Pharmaceutical Association, on new Grant Thornton Study Showing Immediate Need for Biosimilar Competition

Published Online: Friday, February 1, 2013
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WASHINGTON, DC (February 1, 2013) — Today's report from Grant Thornton underscores the need for swift and decisive action to make the promise of biosimilar medicines a reality for the millions of American patients in need of lifesaving biologic treatments. This new report sheds a spotlight on the dramatic untapped opportunity for new, next-level biologic therapies.

Biologic medicines are often the only medicines that can treat life-threatening diseases, but their high price tag can keep them out of reach for many patients. People in many countries around the world already have access to less costly biosimilar version of these medicines. The FDA now is developing regulations that will allow for their approval and use here at home. This report underscores how critical it is that the FDA, the industry, and state governments work together to remove barriers to market entry for biosimilar therapies.

The report noted that over the next four years (by end of 2016), brand biologics with $40 billion in U.S. sales will come off patent. Combining that number with the more than $20 billion in brand biologics that are already off patent, this represents more than $60 billion in annual spending in the U.S. Even with the most conservative estimates, this report shows that biosimilars hold the potential to save $20 billion annually. At a time when policymakers are in dire need of healthcare savings, we cannot afford to leave $20 billion on the table. This report also demonstrates why current efforts by Amgen and Genentech to limit future access to biosimiliars in the states must be defeated by state legislatures.

As proven with traditional chemical prescription drugs, competition from biosimilars in the biologics market will results in lower costs for patients and payers. GPhA urges the FDA to move expeditiously in developing the biosimilar approval process to assure timely availability of safe, effective and less-costly biosimilar medicines.

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“GPhA applauds FDA for taking helpful steps to address, and hopefully limit, scenarios in which some brand drug companies misuse Risk Evaluation and Mitigation Strategies programs to thwart competition from more affordable generic drugs. The ongoing abuse of REMS and REMS-like programs costs the American health system and its patients $5.4 billion annually, according to a study conducted by Matrix Global Advisors. Interestingly, as the United States market readies for biosimilars, this same study identifies $140 million in lost savings that would occur for every $1 billion in biologics sales.
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