December 9, 2011
Robust clinical trials will ensure that biosimlars are safe and effective for patients Washington, D.C. – The Alliance for Safe Biologic Medicines (ASBM), a national not-for-profit organization dedicated to ensuring patient safety and access to biologic medicines, welcomes the first steps from the U.S. Food and Drug Administration (FDA) to bring biosimilars on the market […]
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 6, 2011
September 10-12, 2012 San Antonio, Texas Read More
December 1, 2011
Presented by Dr. Richard Dolinar, MD What are biosimilars Why are biosimilars not generics Manufacturing The FDA’s “biosimilar pathway” Policy Considerations
November 17, 2011
Presented by Alliance Chairman, Dr. Richard Dolinar, MD Role of biotechnology in medical advancements What are biologics Examples of biologic medicines Manufacturing process Chemical drugs vs. biologic medicines Implications of size, variability, complexity What’s next for biotechnology
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 […]
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. […]
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 […]
