ASBM Statement on Senate HELP Committee Passage of Biosimilar Red Tape Elimination Act

Statement of the Alliance for Safe Biologic Medicines on Senate HELP Committee Passage of the Biosimilar Red Tape Elimination Act (S. 1954)
June 17, 2026

The Alliance for Safe Biologic Medicines (ASBM) is deeply disappointed that the Senate HELP Committee today advanced the Biosimilar Red Tape Elimination Act (S. 1954).

S. 1954 does not eliminate red tape—it eliminates FDA’s authority to make product-specific scientific determinations regarding interchangeability; that is, whether switching a patient from one biologic medicine to a biosimilar may affect treatment safety or efficacy. Under current state laws, only FDA-designated interchangeable biosimilars may be substituted without physician involvement, as generic drugs might be.

Instead, S. 1954 would simply declare all biosimilars interchangeable by law.

“Congress created a separate approval pathway for biosimilars because they are fundamentally different from generic versions of small-molecule drugs, a fact recognized by the FDA and all major medicines regulators worldwide,” says ASBM Executive Director Michael Reilly, Former Associate Deputy Secretary for Health, U.S. Department of Health and Human Services.  “The science doesn’t change just because the law does.  FDA is obliged to evaluate whether generics are safe for switching – because some are not.  Patients deserve the same rigor for biologic medicines – which are larger and more complex than generics-  but S.1954 would eliminate FDA’s  authority to do so. “

Substitution of biosimilars by someone other than the prescribing physician is highly controversial, rare, and often banned in countries with scientifically sound and respected regulatory systems, including throughout most of Europe.

U.S. physicians overwhelmingly oppose the “genericization” of biosimilars: a recent survey showed 88% support maintaining FDA’s current product-specific review of interchangeability, while only 11% support automatically deeming all biosimilars interchangeable.

“Physicians oppose this legislation by nearly nine to one because they understand something Congress appears to have forgotten: treatment plans are not one-size-fits-all,” says ASBM Chairman Ralph McKibbin, MD. “Many patients spend years finding a biologic therapy that controls their disease. This bill not only removes FDA’s scientific judgment from the equation, it also removes the physician’s judgement- letting insurers and PBMs make treatment decisions based on profitability, not what’s best for the patient.”

For more detail how S. 1954 moves biosimilar policy in the wrong direction, ASBM encourages policymakers, physicians, patient advocates, and other stakeholders to review the following resources:

###