Biosimilars Blog – Safe Biologics

New ASBM Infographic Tells Congress: “Proceed with Caution; Patients at Risk”

September 2, 2026

ASBM has released a new fact sheet explaining the risks posed by the Biosimilar Red Tape Elimination Act (BRTEA, S. 1954). Today, FDA evaluates each biosimilar individually before determining whether it is interchangeable—meaning it may be substituted at the pharmacy without the prescribing physician’s approval. BRTEA would eliminate that product-by-product scientific review and automatically deem […]

Erratic FDA Leadership is Creating a Crisis of Confidence

February 22, 2026

by Michael Reilly, ASBM Executive Director It feels impossible these days to go a single week without news of another shocking policy move from the U.S. Food and Drug Administration that upends decades-old scientific consensus or agency norms regarding clinical safety data and drug approval standards. Consider the most recent example. Earlier this month, the […]

Trust is Built on Data: Preserving the FDA’s Evidence-Based Approach to Interchangeable Biosimilars

May 8, 2025

By Michael Reilly, Executive Director, Alliance for Safe Biologic Medicines (ASBM) In a recent CBS News interview, newly appointed FDA Commissioner Dr. Marty Makary called for more robust clinical evidence before recommending the latest COVID-19 booster shots. “There’s a void of data,” Dr. Makary said, underscoring a renewed focus on restoring public trust through a […]

Biden Budget Would Allow Automatic Pharmacy Substitution of ALL Biosimilars, Misunderstands US and EU Substitution Policy

April 11, 2024

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 […]

ASBM’s Comments on the Medicare Drug Price Negotiation Plan: Protecting Patients and Ensuring Access to Medicines

April 25, 2023

By Michael Reilly, Executive Director, Alliance for Safe Biologic Medicines (ASBM) ASBM recently submitted comments 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 […]

ASBM Adds Module on PBM Practices to Ohio State University Biosimilars Course

January 10, 2023

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 […]

ASBM/Ohio State University Biosimilars CE Course Adds New Module on Patient Perspectives

November 1, 2022

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 […]

ASBM’s Schneider Discusses Pharmacist, PBM Role at National Policy & Advocacy Summit on Biologics

October 19, 2022

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 […]

ASBM’s Schneider Discusses Pharmacist, PBM Role at National Policy & Advocacy Summit on Biologics

October 19, 2022

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 […]

OSU College of Pharmacy Adds Two New Modules to ASBM CE Course

September 4, 2022

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, […]