by Michael Reilly, ASBM Executive Director The Biden Administration’s FY25 Budget, unveiled on March 11, 2024, takes aim at prescription drug costs but misses the mark and hurts rather than helps patients. Again. (Read my concerns with the Administration’s Medicare Part D price-setting system here). This latest proposal would loosen the review criteria for some biologics and shift treatment decisions out of the hands of doctors.  This proposal is built on a misunderstanding surrounding substitution of medicines and in particular the definition of the word “interchangeable” as it is used ..read more

By Michael Reilly, Executive Director, Alliance for Safe Biologic Medicines (ASBM) ASBM recently submitted to the Centers for Medicare & Medicaid Services (CMS) on the proposed Medicare Drug Price Negotiation Plan. Under this plan – authorized by the Inflation Reduction Act (IRA) signed in to law last year – Medicare will “negotiate” (set) maximum fair prices (MFPs) for many expensive medications. Having served in the Department of Health and Human Services’ Office of the Secretary from 2002-2008, including two years as Associate Deputy HHS Secretary, I participated in the development and ..read more

In December, ASBM recorded the seventh and final module in its biosimilar Continuing Education (CE) Course on Biosimilars, presented with the Ohio State University College of Pharmacy. The latest module is entitled “PBMs and Payer Practices” and is presented by ASBM’s Immediate Past Chair Madelaine Feldman, MD, FACR. In this module Dr. Feldman explains unique features of the U.S. drug distribution system, with an emphasis on payer and pharmaceutical benefit manager (PBM) practices regarding biologic medicines and biosimilars. The bifurcated U.S. system (provider-administered vs. self-administe ..read more

In October, ASBM recorded the latest entry in its ongoing continuing education (CE) series in partnership with the Ohio State University College of Pharmacy. This course module, entitled “Patient Perspectives on Biosimilars”, represents part 6 of the 7-part series covering a wide range of biosimilar policy issues. In this module, participants will hear different perspectives from the patient community regarding biosimilars and how they are made available to patients. ASBM Steering Committee Member Andrew Spiegel will share his perspective as the head of two international patient orga ..read more

On October 19th, ASBM Advisory Board Chair Philip Schneider participated in the 7th Annual National Policy & Advocacy Summit on Biologics, The event was hosted in Washington, DC by the Biologics Prescribers Collaborative and was also streamed online. Professor Schneider appeared on the opening panel discussion entitled “The Emerging Biologics Landscape”, which also featured Chad Pettit, Executive Director of Marketing at Amgen, and Wesley Mizutani, MD, a rheumatologist with Optum Medical Group. The discussion was moderated by David Charles, MD, founder of the Alliance for Pa ..read more

In August, ASBM recorded two new entries in its ongoing continuing education (CE) series in partnership with the Ohio State University College of Pharmacy. These represent part 4 and 6 of the 7-part series covering a wide range of biosimilar policy issues. View the previous three entries here. Module 4: Physician Perspectives on Biosimilars In this module, ASBM Chair Ralph McKibbin, MD FACP FACG AGAF shares survey data from physicians in 13 countries, including U.S. (n=401, 2021) and Europe (n=579, 2019). Physician attitudes on a variety of aspects of biosimilars are examin ..read more

On May 31st, the Ohio State University College of Pharmacy released a series of promotional videos for its 7-hour continuing education (CE) program on biosimilars. The videos consist of an overview of the educational program featuring all the presenters, as well as a biographical sketch of each presenter. The program was developed in partnership with ASBM and covers a broad variety of biosimilar topics. ASBM The program is fully ACPE-accredited and available to pharmacists nationwide.The course consists of seven modules, of which the first three are currently available. Additional mo ..read more

On September 28th, ASBM Advisory Board Chair Philip Schneider presented an online Continuing Education (CE) course entitled the “The State of the Biosimilars Market in 2021”. The course was presented in conjunction with Long Island University College of Pharmacy and is the third in the series “Biosimilars: What Pharmacists Need to Know”. The series is accredited by the American Council on Pharmaceutical Education (ACPE). In the presentation, Dr. Schneider discussed the potential economic benefits of biosimilars, and examined different approaches countries around the world have u ..read more

ASBM, in conjunction with the Long Island University College of Pharmacy (LIU-Pharmacy), is now offering a comprehensive continuing education course on biosimilars entitled “Biosimilars: What Pharmacists Need to Know”. The second course in the series,”Substitution and Non-Medical Switching” has been updated to include discussion of the July 28 approval of the first interchangeable biosimilar insulin. The course is presented by ASBM Advisory Board Chair Philip Schneider and covers many topics including: Why Should Pharmacists Care About Biosimilars? Terminology Review: Biologics, Bio ..read more

By Michael Reilly, Executive Director, Alliance for Safe Biologic Medicines (ASBM) ASBM recently submitted to the Centers for Medicare & Medicaid Services (CMS) on the proposed Medicare Drug Price Negotiation Plan. Under this plan – authorized by the Inflation Reduction Act (IRA) signed in to law last year – Medicare will “negotiate” (set) maximum fair prices (MFPs) for many expensive medications. Having served in the Department of Health and Human Services’ Office of the Secretary from 2002-2008, including two years as Associate Deputy HHS Secretary, I participated in the development and ..read more