Biosimilars

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 […]

KevinMD: Involve Doctors in Any Drug Substitution Process Involving Biosimilars

April 17, 2012

by RICHARD DOLINAR, MD As a treating physician who also serves as the Chairman of the Alliance for Safe Biologic Medicines (ASBM), I have been watching with great interest as the Food and Drug Administration (FDA) begins to unveil the approach it will take to bring “biosimilar” medications to the US. Biosimilars are attempts to […]

A Safe Pathway to Biosimilars

April 11, 2012

By Dr. Richard Dolinar Chairman of the Alliance for Safe Biologic Medicines (Published April 5, 2012) Excerpt: Recently, the FDA issued a series of draft guidance documents that outlined the approach the agency would take to make biosimilars available for patients in the U.S. While the guidance documents emphasized that the FDA was rightly focused […]

Safe Biologics

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

KevinMD: Involve Doctors in Any Drug Substitution Process Involving Biosimilars

A Safe Pathway to Biosimilars

Biologic Drugs: Biosimilars May Be Cheaper, But Are They Safe?

FDA must establish safe approval pathway for biosimilar drugs

FDA must establish safe approval pathway for biosimilar drugs

Proceed with caution on creating ‘biosimilar’ drugs

Proceed with caution on creating ‘biosimilar’ drugs