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 […]
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. […]
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. […]
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 […]
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 […]
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 […]
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 […]
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 […]
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 […]
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 […]
