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 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 5, 2011
By Kathy Feegal Dr. Richard Dolinar, the Alliance’s chairman, was a keynote speaker at a biosimilars roundtable discussion in Boston, MA on October 5, 2011. The event was hosted by Northeastern University and was attended by numerous stakeholders from across New England, including the Massachusetts Medical Society, and patients groups such as the National Kidney […]
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 28, 2011
The Alliance for Safe Biologic Medicines joined with the Virginia Biotechnology Association at an event to expore with patients, advocates, physicians and other healthcare providers the importance of maintaining patient safety as the U.S. FDA’s top priority while it works to establish a pathway for approval for biosimilar products.
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 […]
