Safe Biologics

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Latest News

Fact Sheet: Stop the “Genericization” of Biosimilars

The world’s regulators agree: Biosimilars aren’t generics. Why is the FDA suddenly pretending they are?

ASBM Submits Comments Urging FDA to Maintain Stringent Approval Standards, Opposing “Genericization” of Biosimilars

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 […]

A Step Backward for Medication Safety and Confidence: FDA’s New Biosimilar Plan Revives Biden-Era “Genericization” Policy

October 31, 2025 ASBM: Biosimilars are not generics—so why is FDA pretending they are? Learn more: ASBM Fact Sheet- Stop the “Genericization” of Biosimilars WASHINGTON, D.C. — The Alliance for Safe Biologic Medicines (ASBM) today expressed strong opposition to the Department of Health and Human Services’ continuation of a Biden-era regulatory initiative that inaccurately portrays biosimilars as “generic […]