February 2, 2018
On January 29th, Alex Azar was sworn in as Secretary of the Department of Health and Human Services (HHS) by Vice President Mike Pence following remarks by President Trump. ASBM Executive Director Michael Reilly, who served as Mr. Azar’s Deputy from 2005-2007, was in attendance. Mr. Azar previously spent four years as the Department’s […]
January 26, 2018
On January 24th, the Australian Therapeutic Goods Administration (TGA) released the response to its recent stakeholder consultation on biosimilar naming. The regulator sought input on whether or not it should use distinguishing suffixes for biologics and biosimilars to improve product identification and adverse event reporting. A suffix approach is currently supported by the World […]
January 5, 2018
On January 4th, the Roanoke Times published an op-ed by Stacie Phan, Executive Director of the Biosimilars Forum, discussing the potential cost savings of biosimilars, especially to the Medicare program: “…a recent decision by the Centers for Medicare & Medicaid Services to change a billing policy that jeopardized the long-term stability of the biosimilars market could also help pave the way for […]
December 25, 2017
On December 25th, the Vancouver Sun published an op-ed authored by ASBM Executive Director, Michael Reilly, regarding the topic of Non-Medical Switching of biosimilars. Non-Medical Switching is when a biosimilar is substituted by a third party in place of the biologic medicine prescribed by the physician, for reasons other than the patient’s health or safety. In the […]
December 7, 2017
The Alliance for Safe Biologic Medicines conducts regular surveys to better understand physicians’ perspectives on originator biologics and biosimilars. The organization recently released its 2017 Canadian Prescriber Survey. The survey reveals Canadian physicians’ attitudes on a number of critical policy issues surrounding the approval and use of originator biologics and biosimilars. 83 per […]
November 15, 2017
By Michael Reilly Executive Director, ASBM Prior to serving as ASBM’s Executive Director, I worked from 2002-2008 at the U.S. Department of Health and Human Services (HHS), including three years as Associate Deputy Secretary under Alex M. Azar, who was nominated recently as HHS Secretary. As a former health regulator, I understand the challenges we face when trying […]
November 5, 2017
On October 23rd, the FDA launched a robust online resource center aimed at educating prescribers on biosimilars. The website includes fact sheets which explain regulatory terminology such as, “reference product” and “interchangeability”. The fact sheets also detail the biosimilar approval process as well as explain how these medicines are prescribed and substituted. Sections include: Biosimilar and Interchangeable Products; Biosimilar Development, […]
November 5, 2017
On Monday, October 23rd, Governor Andrew Cuomo signed biosimilars legislation (S.4788A/A.7509A) regarding the pharmacy substitution of interchangeable biosimilar medical products—a measure ASBM and others have pursued in New York over the past two years. New York is now the 36th state to pass biosimilars substitution legislation. This law (Chapter 357 of the Laws of 2017) […]
November 5, 2017
On November 2nd, 2017, the Centers for Medicare and Medicaid Services (CMS) issued a final rule for the 2018 Physician Fee Schedule, which governs reimbursement rates for physicians. In a significant development, beginning in 2018 CMS will update payment for biosimilars. Under the previous rule finalized in 2015 under the Obama Administration, all of the biosimilars sharing one reference […]
