Interview with Bloomberg BNA
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.
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
On April 23, Michael Reilly participated in the Food and Drug Law Institute (FDLI) 2013 Annual Conference, speaking on a panel on the priorities and challenges facing the FDA and the Center for Biologics Evaluation and Research (CBER). Following presentations by CBER officials, Diane Maloney, Associate Director for Policy, and Mary Malarkey, director in the […]
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 From FDA Draft Guidance Sets Rules for Biosimilar Meetings: The FDA recently tiptoed into largely uncharted waters, issuing draft guidance laying out the ground rules for formal meetings between review staff and makers of biosimilars.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 […]
March 15, 2013
On March 14, ASBM Advisory Board Member, Dr. Harry Gewanter was quoted in the Inside Health Policy Article “North Dakota Projects Lost Savings With Biosimilar Bill; Cost Debate Heats Up.” The article says: “Harry Gewanter, a pediatric rheumatologist and Alliance for Safe Biologic Medicines board member, rebutted arguments from the sponsor of the Virginia bill, […]
March 15, 2013
On March 14, Dr. Dolinar gave a presentation on a “Clinicians’ Perspective on Biosimilars” at the Biosimilar Insulins Impact on Clinical Practice Publications Roundtable Meetings in Dallas. View his presentation here.