Fact Sheet: Stop the “Genericization” of Biosimilars
November 5, 2025
The world’s regulators agree: Biosimilars aren’t generics. Why is the FDA suddenly pretending they are?
Latest News
ASBM Submits Comments Urging FDA to Maintain Stringent Approval Standards, Opposing “Genericization” of Biosimilars
October 21, 2025
On October 19th, ASBM submitted detailed comments to the U.S. Food and Drug Administration regarding its September 19 public workshop, Advancing the Development of Interchangeable Products: Identifying Future Needs (Docket No. FDA-2025-N-2787). ASBM expressed strong concern over signals that FDA may move toward “genericizing” biosimilars—modeling their approval and substitution on small-molecule generics—calling such a shift “scientifically inappropriate […]
ASBM Announces Retirement of Doug Badger,Welcomes Beato and Downing to Board
July 7, 2025
ARLINGTON, VA — July 7, 2025 — The Alliance for Safe Biologic Medicines (ASBM) today announced the retirement of longtime Board member Doug Badger, and the appointment of two new members to its Board of Directors: Cristina V. Beato, MD, and Chris Downing, both of whom previously served in senior leadership roles at the U.S. […]
MFN: Medicines For No-One
June 3, 2025
What is MFN?—Why It’s a Threat to Patients The Most Favored Nation (MFN) drug pricing policy ties U.S. medicine prices to those in countries with strict government price controls. This may sound like a win for patients, but MFN imports the very systems that limit access, delay innovation, and lead to higher death rates abroad—especially […]
ASBM Statement on Executive Order Implementing MFN Pricing
May 15, 2025
Statement from the Alliance for Safe Biologic Medicines (ASBM) on the Administration’s Executive Order Implementing MFN Pricing May 15, 2025 The Alliance for Safe Biologic Medicines (ASBM) opposes the Administration’s May 12, 2025 Executive Order establishing Most Favored Nation (MFN) pricing for prescription drugs. This approach would import foreign price controls from countries where patients […]
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 […]
Statement from the ASBM on Senate HELP Committee 340B Reform Report
April 29, 2025
April 29, 2025 The Alliance for Safe Biologic Medicines (ASBM) commends Senator Bill Cassidy and the Senate HELP Committee for their new report, “Congress Must Act to Bring Needed Reforms to the 340B Program.” The program is designed to support underserved populations by ensuring access to medicines by allowing qualifying entities to safety-net hospitals, community […]
ASBM Statement on President Trump’s Executive Order Supporting Patients Who Depend on Small-Molecule Medicines
April 21, 2025
April 21, 2025 The Alliance for Safe Biologic Medicines (ASBM) commends President Donald J. Trump for his leadership in issuing an executive order to address the harmful “pill penalty” contained within the Inflation Reduction Act (IRA). This provision, enacted during the Biden administration, imposes price controls on small-molecule medicines—commonly delivered in pill or tablet form—just […]
Debunking Misinformation on Interchangeable Biosimilars
March 20, 2025
A recent IQVIA report funded by the generics industry trade group Association for Accessible Medicines is propagating several misleading claims about interchangeable biosimilars. ASBM has frequently addressed misinformation efforts about interchangeablity biosimilars in recent months, to correct the record and reinforce the rigorous FDA standards now protecting patient safety and treatment stability. Here are some […]
ASBM Praises Introduction of the EPIC Act
March 7, 2025
FOR IMMEDIATE RELEASE March 7, 2025 Arlington, VA – The Alliance for Safe Biologic Medicines (ASBM) today expressed its support and gratitude to Senators Thom Tillis (R-NC), Ted Budd (R-NC), Marsha Blackburn (R-TN), James Lankford (R-OK), and Steve Daines (R-MT) for their leadership in introducing the Ensuring Pathways to Innovative Cures (EPIC) Act (S. 832) […]
