Latest News – Page 2 – Safe Biologics

ASBM Urges Congress to Support EPIC Act: Remove IRA’s “Pill Penalty” to Ensure Continued R&D for Small-Molecule Drugs

March 5, 2025

On February 25th, the House of Representatives introduced the Ensuring Pathways to Innovative Cures (EPIC) Act (H.R. 1492) an important step toward fixing the Inflation Reduction Act’s (IRA) small molecule pill penalty. Small-molecule drugs typically come in pill or tablet form, and comprise 90% of prescriptions filled in the U.S. The Senate introduced its companion […]

ASBM’s Dr. Feldman Participates in Capitol Hill PBM Forum

February 27, 2025

On February 25th, ASBM’s Immediate Past Chair Madelaine Feldman, MD FACR joined Members of Congress and other high-profile supporters of PBM reform at a Congressional event urging leadership to include critical bipartisan PBM reform legislation in the anticipated March funding package. The event, titled “Finish the Job! Pass PBM Reform Now” included welcome remarks from […]

ASBM/Ohio State University College of Pharmacy Course Examines Impact of Lowering Interchangeable Biosimilar Standards, IRA

February 25, 2025

On February 20th, Philip Schneider, ASBM Advisory Board Chair, taught a 2-hour class at the Ohio State University College of Pharmacy that examined how recent and proposed biosimilar policy changes may impact pharmacy practice within the biopharmaceutical industry. The module examined three current policy issues related to biosimilars: Pharmacy students were given basic information about […]

ASBM Responds to PCMA: Put Patients First, Not PBM Profits

December 12, 2024

Press Release ARLINGTON, Va., December 9, 2024 (Newswire.com) – As the Senate moves this week to advance passage of the misleadingly named Biosimilar Red Tape Elimination Act (S. 2035), the Alliance for Safe Biologic Medicines (ASBM) reiterates its opposition to the self-interested efforts of the Pharmaceutical Care Management Association (PCMA), which strongly supports this bill that […]

Myth vs Fact: The Biosimilar Red Tape Elimination Act

November 14, 2024

Click here to download the Myth vs Fact Onepager.

ASBM Physician Survey on Interchangeable Biosimilars Finds Support for Maintaining Current Standards

October 13, 2024

U.S. Physicians Overwhelmingly Support Current FDA Data Standards, Switching Studies for Interchangeable Biosimilars; Oppose Pharmacy Substitution of Non-Interchangeable Biosimilars FOR IMMEDIATE RELEASE– September 4, 2024 Arlington, VA- U.S. physicians overwhelmingly support maintaining the Food and Drug Administration’s (FDA’s) current data standards for interchangeable biosimilars and oppose treating all biosimilars as interchangeable with the originator biologic […]

Dr. McKibbin Op-ed: Lowering Interchangeable Biosimilar Standards Endangers Patient Health

October 5, 2024

Lower med standards endangers health Altoona Mirror Opinion Oct 2, 2024 Dr. Ralph McKibbin As a practicing physician in Pennsylvania, I firmly believe that the relationship between a doctor and their patient should guide every treatment decision. When physicians recommend treatments, we rely on years of training, clinical evidence, and the unique medical history of […]

Michael Reilly: Congress Should Maintain Current FDA Biosimilars Standards

September 27, 2024

Prioritize Patient Treatment Stability, Physician Confidence Michael ReillySeptember 25, 2024 Biologic medicines have revolutionized the treatment of serious chronic diseases including, arthritis, psoriasis, Crohn’s disease, and cancer. Nearly 10 years ago, the FDA approved the first “biosimilar” – a copycat medicine highly similar, but not identical to a previously-approved biologic. Biosimilars offer new treatment choices […]

Fact Sheet: Physicians Oppose S.2305 -That Would Make All Biosimilars Interchangeable

August 27, 2024

ASBM Submits Comments on FDA Draft Guidance Proposing Eliminating Switching Studies for Interchangable Biosimilars

August 27, 2024

On August 20th, ASBM submitted comments on the FDA draft guidance for industry entitled “Considerations for Demonstrating Interchangeability with a Reference Product: Update”, published June 20th. This draft guidance describes considerations regarding a switching study or studies intended to support a demonstration that a biological product is interchangeable with a reference product. From ASBM’s comments: In addition to the FDA […]