October 28, 2013
The Alliance for Safe Biologic Medicines (ASBM) executive director, Michael Reilly, was featured in a Globe & Mail video series on biosimilars. Mr. Reilly provides a global perspective on biosimilars, with a focus on why manufacturing matters. Globe & Mail is the national newspaper for Canada and this new online series will provide viewers with […]
October 10, 2013
Dolinar Letter to the Editor Published by GaBI in Advance of WHO Naming Meeting On September 27th, a Letter to the Editor by ASBM Chairman Richard Dolinar, M.D. was featured in the Generics and Biosimilars Initiative Journal (GaBI). The piece commends the World Health Organization (WHO) for its attention to an upcoming action on the […]
September 20, 2013
WASHINGTON, DC – Alliance for Safe Biologic Medicines (ASBM) chairman, Richard Dolinar M.D., added a physician’s perspective to the ongoing discussion around the naming of biologic medicines, including biosimilars. “Biologics are highly sensitive to the manufacturing process and their environment; slight differences can have unexpected results,” stated Dolinar. “As a physician, patient safety is paramount. […]
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 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 From FDA Draft Guidance Sets Rules for Biosimilar Meetings: The FDA recently tiptoed into largely uncharted waters, issuing draft guidance laying out the ground rules for formal meetings between review staff and makers of biosimilars.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 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 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 […]
November 30, 2012
The US-based Alliance for Safe Biologic Medicines (ASBM) announced on 28 November 2012 that its recommendations with respect to identification and substitution of biosimilars have been published in the Food and Drug Law Institute (FDLI) policy forum. The paper titled ‘It’s all about the name: what is the imperative of adopting unique names for biologic […]
