About the FDA and Biosimilars

November 4, 2011

By Bruce Rubin MedPage Today Although politicians and patients may debate the benefits and drawbacks of the U.S. healthcare system, when it comes to inventing new medical technologies and discovering life-saving treatments, no other nation matches the U.S. in terms of innovation and delivery of care. One reason the U.S. is so successful is that […]

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FDA’s “Pathway on Biosimilars” Forthcoming

October 6, 2011

The FDA’s Janet Woodcock recently appeared on BioCenturyTV and in a web exclusive she addresses a potential ‘biosimilars pathway’. Though she declined to comment on the specific clinical and nonclinical standards, she made clear that the approval pathway for a biosimilar is different from that of a biologic. She also said that biosimilar interchangeability is […]

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Drug costs, benefits must align

October 5, 2011

Dr. David Charles, Chairman, Alliance for Patient Access The Tennessean In 1993, a drug just approved by the Food and Drug Administration was highlighted in a Fortune magazine article under the eye-catching headline “Fortune Products of the Year.” The drug was Betaseron. And while the headline was ambitious, the new drug was a medical triumph. […]

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New medicines bring hope, safety concerns

September 10, 2011

By Kara Nett Hinckley, Public Policy Coordinator, Colorado Chronic Care Collaborative Denver Post How many of us have watched a loved one or friend suffer from a serious illness and wished for a miracle treatment that could help them with their struggle? Biologic drugs are not miracles, but they are a new, often better way […]

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Patient safety is essential for new cancer meds

August 25, 2011

By Andrew Spiegel, CEO, Colon Cancer Alliance The Patriot-News The lead article in this month’s New England Journal of Medicine was a perspective piece written by key Food and Drug Administration officials on the development of America’s biosimilars program. Biosimilars are the imitative versions of biologic medicines, the miracle drugs to treat serious conditions such […]

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Is the FDA writing a recipe for the failure of biosimilars in the U.S.?

August 8, 2011

FierceBiotech By John Carroll Will FDA officials raise the regulatory bar on biosimilars so high they can’t be competitive in the U.S.?  Longtime researcher and Parexel consultant Dr. Saurabh Aggarwal seems to think there’s a very high risk of that. In an interview with Scientific American blogger Khadijah Britton, Aggarwal says that the FDA’s latest […]

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Biosimilars: US payers “will want more data than FDA”

August 5, 2011

PharmaTimes By Lynne Taylor To feel comfortable with generic biologics (biosimilars), US payers are likely to require more clinical information than what might be accepted by the Food and Drug Administration (FDA) for approvals, a new report suggests. For example, FDA approval of biosimilar versions of monoclonal antibodies (MAbs) for oncology indications will not allay […]

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Developing the Nation’s Biosimilars Program

August 4, 2011

Developing the Nation’s Biosimilars Program Steven Kozlowski, M.D., Janet Woodcock, M.D., Karen Midthun, M.D., and Rachel Behrman Sherman, M.D., M.P.H. New England Journal of Medicine August 4, 2011 Biologic products developed over the past three decades and approved by the Food and Drug Administration (FDA) now provide important therapeutic options for a variety of serious […]

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FDA gives glimpse of biosimilar approval process

August 3, 2011

Reuters By Anna Yukhananov Evaluating generic versions of complex biotechnology medicines will require a new, more rigorous review process, U.S. drug regulators said, in the first glimpse of their thinking on the subject. Drugmakers, investors and others have been clamoring for more insight into the approval process for cheaper versions of biotech drugs, known as […]

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New medicines offer hope, require caution

August 1, 2011

By Helena R. Berger, Executive Vice President & CEO, American Association of People with Disabilities Buffalo News The future of medicine is biologic drugs. Not only have they revolutionized the medical treatments of serious diseases, they have also transformed treatments for many people with disabilities – from offering new promise to people with multiple sclerosis […]

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