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 From FDA Draft Guidance Sets Rules for Biosimilar Meetings: The FDA recently tiptoed into largely uncharted waters, issuing draft guidance laying out the ground rules for formal meetings between review staff and makers of biosimilars.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 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 From FDA Draft Guidance Sets Rules for Biosimilar Meetings: The FDA recently tiptoed into largely uncharted waters, issuing draft guidance laying out the ground rules for formal meetings between review staff and makers of biosimilars.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 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 […]
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 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, 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.
March 12, 2013
ASBM Executive Director Michael Reilly was quoted in a BNA article on biosimilar state legislation. Reproduced with permission from Pharmaceutical Law & Industry Report,11 PLIR 286 (March 1, 2013). Copyright 2013 by The Bureau of National Affairs, Inc. (800-372-1033) <http://www.bna.com> (BNA) — Will State Laws Thwart Use of Biosimilars? Major Development: Several states are considering […]
