December 15, 2011
By Dr. Marcy Zwelling-Aamot, chairperson of the Board of the American Academy of Private Physicians (AAPP) The Hill The U.S. Food and Drug Administration (FDA) is holding an important public meeting today on its proposed biosimilar user fee program recommendations. This meeting is a major step in making biosimilars available for the first time in […]
December 7, 2011
Emerging patient safety issues under health care reform: follow-on biologics and immunogenicity By Bryan A. Liang and Timothy Mackey Therapeutics and Clinical Risk Managment Abstract: US health care reform includes an abbreviated pathway for follow-on biologics, also known as biosimilars, in an effort to speed up access to these complex therapeutics. However, a key patient […]
December 7, 2011
Emerging patient safety issues under health care reform: follow-on biologics and immunogenicity By Bryan A. Liang and Timothy Mackey Therapeutics and Clinical Risk Managment Abstract: US health care reform includes an abbreviated pathway for follow-on biologics, also known as biosimilars, in an effort to speed up access to these complex therapeutics. However, a key patient […]
November 12, 2011
Alliance for Safe Biologic Medicines Launches Webinar Series Starting in November, The Alliance for Safe Biologic Medicines will host several webinars on biologic and biosimilar medicines, hosted by Alliance Chairman Dr. Richard Dolinar. Registration is free! Biologics 101: What are biologics and why should you care? Thursday, November 17, 2:30 PM EST Click here to […]
November 12, 2011
Alliance for Safe Biologic Medicines Launches Webinar Series Starting in November, The Alliance for Safe Biologic Medicines will host several webinars on biologic and biosimilar medicines, hosted by Alliance Chairman Dr. Richard Dolinar. Registration is free! Biologics 101: What are biologics and why should you care? Thursday, November 17, 2:30 PM EST Click here to […]
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 […]
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 […]
