June 27, 2013
WASHINGTON, DC- The Alliance for Safe Biologic Medicines (ASBM) is pleased to announce the addition of EuropaBio to its membership. EuropaBio is the European Association for Bioindustries, bringing together bioscience companies from all fields of research and development, testing, manufacturing and distribution of biotechnology products. It has 56 corporate members, 14 associate members and Bio […]
June 25, 2013
BOSTON, Mass. — Speaking at the 49th Annual Drug Information Association (DIA) Conference, Dr. Richard Dolinar, chairman of The Alliance for Safe Biologic Medicines (ASBM), presented an analysis of past drug shortages and discussed how policies toward biologic drugs can be developed to guard against short supply. Dr. Dolinar’s presentation, entitled “Characterizing Drug Shortages and Their Causes: Anticipated Future Trends,” stresses that quality and consistency are vital for ensuring a steady and safe supply of biologic medicines for patients.
May 16, 2013
Executive Director Michael Reilly spoke with Bloomberg BNA on the challenges facing the biosimilars process both in the U.S. and abroad. View the Video Insights interview here.
April 26, 2013
By Gerald Felando Affordable, quality health care is a mainstay topic in today’s media and will continue to be, especially here in Sacramento. As a dentist, cancer survivor and former member of the California Assembly, I know the importance of creating policy that is patient-centered. The delivery of optimal health care for patients is constantly […]
April 26, 2013
In Florida’s House and Senate, lawmakers are currently working on legislation that would enable patients to purchase lower-cost alternatives to some of today’s most-advanced medicines. Unfortunately, a recent amendment to the legislation undermines the physican-patient relationship. It’s critical for lawmakers to revert to their original proposal. The legislation under consideration deals with a new class […]
April 17, 2013
ASBM Executive Director Michael Reilly was quoted in the FDA News article by Robert King. From FDA Draft Guidance Sets Rules for Biosimilar Meetings: The FDA recently tiptoed into largely uncharted waters, issuing draft guidance laying out the ground rules for formal meetings between review staff and makers of biosimilars. The document, which provides particulars […]
April 4, 2013
ASBM Advisory Board Member Dr. Bruce Rubin op-ed in the Florida Sun Sentinel: The diagnosis of a chronic, neurological condition like Multiple Sclerosis can be a shock to a patient and his or her family. From my experience as a neurologist, families often have a barrage of questions after receiving this news: Can it be […]
April 2, 2013
In “Profits at center of biosimilars debate” [March 18], the author refers to attempted copies of biotech medicines as “generic biotech medicines.” This demonstrates a fundamental misunderstanding of biosimilars. Biologics are complex molecules that cannot be copied, whereas generics are exact copies of chemical drugs. Failure to understand this distinction results in a failure to […]
March 27, 2013
State Activity More than 15 state legislatures have introduced legislation on substitution over the past few months and ASBM and our members have been very active sending letters of support, testifying at hearings and briefing state legislators on the issue of interchangeability and the need for physician notification. Virginia and North Dakota have both signed […]
March 27, 2013
State Activity More than 15 state legislatures have introduced legislation on substitution over the past few months and ASBM and our members have been very active sending letters of support, testifying at hearings and briefing state legislators on the issue of interchangeability and the need for physician notification. Virginia and North Dakota have both signed […]
