Previously, we reported that biosimilar treatments can improve patient access to care, increasing the number of medication options with the potential to lower their costs. Biosimilars are highly similar to existing biologic medications approved by the U.S. Food & Drug Administration (FDA) and have no clinically meaningful differences from their reference products.1
The ACR supports biosimilars to increase patient access to specialty drugs and reduce costs, but opposes insurer-mandated or frequent non-medical switching, step edits, or excessive out-of-pocket costs for all biologics and biosimilar counterparts. The ACR stresses that FDA labels must clearly indicate interchangeability, delineate all approved indications and specify if supporting data came from the biosimilar or the reference biologic. The ACR remains concerned about the role of payers and pharmacy benefit managers (PBMs) in mandating the choice of therapy, especially if formulary placement or cost savings are prioritized over the appropriateness of a particular therapeutic agent.
Legislation filed in Congress, the bipartisan Biosimilars Red Tape Elimination Act (S. 1954), would remove the distinction between biologics and interchangeable biosimilars to increase medication access and reduce patient costs.2,3 If passed, upon medication approval all biosimilar therapies would be deemed interchangeable. Those supporting this legislation hope it would streamline the regulatory process by removing the unnecessary distinction between biosimilars and interchangeable biologics. Those opposing the legislation are concerned it could weaken regulatory standards, potentially jeopardizing patient health. There are also concerns for physician confidence in prescribing interchangeable biosimilars for patients who are stable on their current treatments.
New Action
On Oct 28, the FDA announced new draft guidance to accelerate approval and acceptance of biosimilar treatments, eliminating comparative clinical efficacy study requirements—often called switching studies—for biosimilar medications.4 Switching studies often lead to a delay in FDA approval for biosimilar medications.
The new draft guidance also addresses that FDA would prefer all biosimilars to be designated as interchangeable with their reference products. This change would not limit the use of some agents used over others and would remove a delay in prescribing, enabling the use of all available biosimilar products. If all biosimilar medications are interchangeable with their respective reference products, this change could increase availability for providers and their healthcare teams, giving them the ability to substitute lower cost biosimilar (biologic) medications. A goal of the FDA is to double or triple the number of biosimilars approved.
Take Action
The ACR will be commenting on the draft guidance in January on behalf of its 10,000+ members. The comment period for this draft guidance is 60 days. The draft document is available for public review and comment. All comments must be submitted by Jan. 20, 2026.
Submit written comments via mail to the Dockets Management Staff (HFA-305), U.S. Food & Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. All comments should be identified with docket number FDA-2011-D-0605. Comments can also be submitted electronically.
The FDA will review and consider all public comments before finalizing the guidance.
Michele B. Kaufman, PharmD, BCGP, is a freelance medical writer based in New York City and a pharmacist at New York Presbyterian Lower Manhattan Hospital.
References
- 9 things to know about biosimilars and interchangeable biosimilars. U.S. Food & Drug Administration. 2024 Jun 20.
- AAM, Biosimilars Council. Letter RE: Biosimilar Red Tape Elimination Act (S. 1954). 2025 Jul 7.
- Hassan M. Lee, Hassan bill cuts drug prices and red tape. 2025 Jun 4.
- Center for Drug Evaluation and Research, Office of New Drugs, Office of Therapeutic Biologics and Biosimilars. Scientific considerations in demonstrating biosimilarity to a reference product: Updated recommendations for assessing the need for comparative efficacy studies. Draft guidance for industry. Docket Number: FDA-2011-D-0605. 2025 Oct 28.