ASBM Submits Comments to Health Canada on Naming

February 10, 2018

On January 18, 2018, the Institute for Safe Medication Practices Canada (ISMP Canada) posted an online questionnaire to seek input from healthcare providers, consumers, and other interested and affected stakeholders on different approaches to the naming of biologic drugs, including biosimilars, in Canada. ASBM submitted comments on February 9th advocating the use of 4-letter suffixes, an approach favored […]

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Alex Azar Sworn in as HHS Secretary 

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 […]

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Biosimilar Innovation Plan Part of FDA’s 2018 Strategic Roadmap

January 12, 2018

On January 11th, the FDA released its 2018 Strategic Policy Roadmap, which outlines its key priorities for 2018, including increasing access to new medicines.   “We know that the cost of product development can impact how such products are priced, and can be a factor in limiting patients’ ability to get timely access to beneficial new treatments […]

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CMS Reversal on Shared Billing Codes Will Save $65 Billion

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 […]

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ASBM Executive Director’s Op-ed Published in Vancouver Sun

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 […]

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Behind the Numbers: A Q&A With ASBM’s Michael Reilly

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 […]

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VIDEO: Canadian Physicians on Non-Medical Switching, Biosimilar Naming

December 7, 2017

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New Leadership Means New Opportunities for Better Policy

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 […]

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FDA Launches Biosimilar Education Site for Prescribers

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, […]

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New York Becomes 36th State to Pass Biosimilar Substitution Law

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) […]

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