Biologics Exclusivity Cut Called for in President’s Budget: All Bark, No Bite

February 14, 2011

The Obama Administration’s fiscal 2012 budget document includes a call to reduce innovator biologics exclusivity from the 12 years just enacted as part of the health care reform law to 7 years, a number more in line with the position supported by advocates on the generic/drug/purchaser/consumer side of the debate. Read More


Next generation biologic drugs provide hope for HIV/AIDS patients

January 26, 2011

James Sykes, Director of Global Policy, The AIDS Institute
The Hill

Our nation’s political capital, Washington D.C. also has the notorious distinction of being the HIV and AIDS capital of the United States, with at least 3 percent of its residents infected. This rate is higher than most countries in West Africa and exceeds the 1% cut-off that marks the U.S. Centers for Disease Control and Prevention’s definition of a generalized epidemic. Many patients with this disease also suffer from complications like kidney failure and anemia. New high-tech therapies for treatment of HIV/AIDS, however, have turned what was once a terminal illness into a potentially chronic, manageable condition.

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Next generation biologic drugs provide hope for HIV/AIDS patients

January 26, 2011

James Sykes, Director of Global Policy, The AIDS Institute
The Hill

Our nation’s political capital, Washington D.C. also has the notorious distinction of being the HIV and AIDS capital of the United States, with at least 3 percent of its residents infected. This rate is higher than most countries in West Africa and exceeds the 1% cut-off that marks the U.S. Centers for Disease Control and Prevention’s definition of a generalized epidemic. Many patients with this disease also suffer from complications like kidney failure and anemia. New high-tech therapies for treatment of HIV/AIDS, however, have turned what was once a terminal illness into a potentially chronic, manageable condition.

Read More


The High Cost of Cheaper Drugs

January 26, 2011

Marcia Boyle, President and Founder, Immune Deficiency Foundation
AOL News

Thirty years ago my infant son was diagnosed with a rare genetic disorder that make even common cold germs potentially life threatening. His disorder — clinically termed a primary immunodeficiency disease — started me on my career as a patient activist.

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Biologic Drugs: Biosimilars May Be Cheaper, But Are They Safe?

December 14, 2010

John Horton, President, LegitScript
Huffington Post

Where there’s medicine, there’s money. That statement should come as no surprise to anyone who has ever looked at a medical bill or filled a prescription: Pharmaceuticals alone are a more than $800-billion market ($300 billion of that is in the United States alone).

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European Union provides a good example of effective biosimilars pathway

December 14, 2010

Biologic drugs can treat a variety of illnesses—including cancer and certain types of arthritis—imore effectively than traditional, chemical based products. For this reason, the medical community is excited about the potential of these so called “miracle drugs.” Continue reading…


European Union provides a good example of effective biosimilars pathway

December 14, 2010

Biologic drugs can treat a variety of illnesses—including cancer and certain types of arthritis—imore effectively than traditional, chemical based products. For this reason, the medical community is excited about the potential of these so called “miracle drugs.” Continue reading…


FDA must establish safe approval pathway for biosimilar drugs

December 14, 2010

Biologic drugs are often referred to as ”miracle drugs“ for good reason—they can often treat serious illnesses such as cancer, rheumatoid arthritis, and multiple sclerosis far more effectively than the traditional chemical drugs that preceded them. Continue reading…


FDA must establish safe approval pathway for biosimilar drugs

December 14, 2010

Biologic drugs are often referred to as ”miracle drugs“ for good reason—they can often treat serious illnesses such as cancer, rheumatoid arthritis, and multiple sclerosis far more effectively than the traditional chemical drugs that preceded them. Continue reading…


Proceed with caution on creating ‘biosimilar’ drugs

November 15, 2010

Dr. Edward Treadwell, Department of Internal Medicine at the Brody School of Medicine at East Carolina University in Greenville, N.C.
Buffalo News

Americans elected a new Congress on Nov. 2, but the voting booth wasn’t the only place where critical issues were at stake that day. Away from the spotlight of election news coverage, a committee of the federal Food and Drug Administration held a hearing in a Washington suburb on the future of biologic drugs, perhaps the most promising health care breakthrough of our lifetime.

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