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GPhA Statement on FTC Report on 'Follow-on Biologic Drug Competition'
Date:6/10/2009

ARLINGTON, Va., June 10 /PRNewswire/ -- The Generic Pharmaceutical Association (GPhA) released the following statement today from GPhA President and CEO Kathleen Jaeger regarding publication of the Federal Trade Commission (FTC) Report on "Follow-on Biologic Drug Competition."

"Today's report from the FTC is yet another endorsement of the need to move forward on passage of legislation that brings affordable biogenerics to patients sooner rather than later. FTC clearly stated that providing the Food and Drug Administration (FDA) with the authority to approve biogenerics would be 'an efficient way to bring these lower-priced drugs to market.' The FTC makes the point that the exclusivity period being pushed by the brands is 'too long to promote innovation.'

"Under Hatch-Waxman, hundreds of millions of patients have benefited from safe, effective and affordable medicines. Moreover, according to a recent IMS Health report, generics have saved the health care system a remarkable $734 billion in the last decade alone. That translates to a savings of one billion dollars every three days - savings that no one thought possible in 1984 and demonstrates the incredibly positive impact that competition has had in the health care marketplace.

"It is important to remember that when Congress debated the Hatch-Waxman Act 25 years ago, the same arguments that we are hearing today about the need for excessive periods of exclusivity, product safety, and generic use by consumers have all been proven wrong. Beyond a shadow of a doubt, Hatch-Waxman has proved that competition from safe and effective generic medicines can truly foster brand innovation while also creating extraordinary savings. Furthermore, when affordable medical options exist, the health care system will adapt and encourage usage.

"As momentum grows on Capitol Hill for passage of biogenerics legislation, both generic and brand companies have clearly stated that they are ready to produce these lifesaving medicines and many are doing so in Europe and around the world.

"In the United States, we have over 42 companies now actively engaged in the biogeneric development. We have seen Teva, Sandoz, Mylan and Momenta as well as major brand companies, such as Merck and Pfizer, all engaged. With both generic and the brand companies wanting to act on biogenerics, it's yet another reason why we believe that, even among the many brand companies, the idea of excessive market exclusivity does not bode well for either brand or the generic companies. Everyone - brand and generic companies alike - wants to compete in this sector much like they do in the pharmaceutical injectable space and that's good news for the pharmaceutical market and, more importantly, good news for patients.

"We can no longer have a health care system where patients only have access to expensive brand biologic medicines, which some expect to comprise half of all the new medicines approved by FDA in 2012. The price of these drugs continues to soar, placing them out of reach of countless Americans. Brand biologics are simply of no use to patients if they can't afford them. And they are also placing an enormous financial burden on our federal government. The federal government through Medicare Part B spent more for EPO in 2007 than FDA had for its entire FY2008 budget. As the FTC report clearly states, biogenerics 'if brought to market, could reduce the estimated $40.3 billion a year consumers spend on biologic drugs.'

"President Obama, many members of Congress of both parties, and now the FTC all believe that FDA can create a biogenerics pathway that ensures a balance between pharmaceutical innovation and consumer access. Our industry's 25 year experience shows this balanced approach not only works, it has allowed consumers to have access to safe, effective affordable medicine, produced significant savings, while fostering innovation. At a time when Americans and our nation are burdened with high health care costs, timely access to affordable biogenerics is the answer to better health."

GPhA represents the manufacturers and distributors of finished generic pharmaceuticals, manufacturers and distributors of bulk active pharmaceutical chemicals, and suppliers of other goods and services to the generic drug industry. Generics represent 69% of the total prescriptions dispensed in the United States, but only 16% of all dollars spent on prescription drugs. For more information about the industry, visit www.gphaonline.org.


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SOURCE Generic Pharmaceutical Association
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