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 versions” of biologic medicines and seeks to eliminate key clinical data requirements that demonstrate biosimilar safety and performance.

“Biosimilars are safe, effective, and affordable alternatives—but they are NOT generics,” said Cristina V. Beato, MD, ASBM Board Member and former Assistant HHS Secretary. “Decades of regulation and law—both in the U.S. and abroad—recognize this indisputable scientific fact. Weakening the data requirements that verify comparable clinical performance would undermine patient and physician confidence at the very moment this Administration claims it wants to restore it.”

The FDA’s own educational materials affirm that “biosimilars are not generics—and important differences exist between them.” Across the world, every competent regulatory authority draws this same distinction:

  • The World Health Organization: “the generic approach is not suitable for the licensing of biosimilars.”
  • The European Medicines Agency: “a biosimilar is not regarded as a generic of a biological medicine.”
  • Health Canada: “unlike generic drugs, biosimilars can never be identical to their reference biologic drug.”
  • Australia’s Therapeutic Goods Administration: “a biosimilar is not a generic biological medicine.”
  • Japan’sPharmaceuticals and Medical Devices Agency: “the approach used for generic chemical drugs is not applicable because the active ingredient of a biosimilar…cannot be completely identical to that of the reference product”
  • Brazil’s ANVISA: “a biosimilar is not an exact replica of the reference…and, hence, cannot be considered as generic.”

Unlike small-molecule drugs, biologics—including biosimilars—require a totality-of-evidence approach: analytical, pharmacologic, and clinical data all play essential roles in ensuring comparable safety and efficacy in patients. Yet the FDA’s new draft guidance claims that comparative clinical studies “often add little value.”

“Analytical testing tells us a lot about the molecule,” said Ralph McKibbin, MD, ASBM Chairman. “But it can’t tell us how that medicine will behave in a patient or account for differences in product delivery devices. Clinical trials can—and do. Treatment plans aren’t one-size-fits-all. Clinical confirmation is what gives prescribers confidence that a biosimilar will work just as well in their patient.”

By resurrecting an ill-conceived Biden-era framework that conflates biosimilars with generics, weakens scientific standards, and elevates political expedience over patient safety, current FDA leadership is taking a step backward—inconsistent with the Administration’s stated goals of gathering more clinical data, ensuring greater transparency, and increasing public confidence in FDA-approved products. 

ASBM urges FDA to reverse course and restore a data-driven biosimilar pathway built on science, transparency, and trust.

ASBM will submit detailed comments to the FDA within 60 days.

Media Contact: Michael Reilly
media@safebiologics.org