Key Takeaway: Proposed federal legislation would eliminate the separate regulatory requirements for interchangeable biosimilars, potentially making it easier for biosimilars to compete with reference biologics.
Congress is considering legislation aimed at simplifying the regulatory framework for biosimilar drugs. The Biosimilar Red Tape Elimination Act, introduced in the Senate as S. 1954[1] and in the House as H.R. 5526, would allow biosimilars approved by the U.S. Food and Drug Administration (“FDA”) to be interchangeable with their reference products, eliminating the need for a separate interchangeability designation.
A biosimilar is a biological product that is highly similar to an FDA-approved reference product (i.e., biologic) and has no clinically meaningful differences from the reference product with regard to safety, purity, and potency.[2] The Biologics Price Competition and Innovation Act (“BPCIA”) establishes a framework for FDA licensure of biosimilar products. Interchangeability, however, currently requires satisfaction of additional statutory requirements beyond those necessary to demonstrate biosimilarity. To be interchangeable, the applicant must demonstrate that the biological product: 1) is biosimilar to the reference product; 2) is expected to produce the same clinical results in any patient; and 3) if administered more than once, poses no greater safety or efficacy risks when alternating with or switching between the reference product compared to using only the reference product.[3] Depending on state laws, an interchangeable biosimilar may be substituted for the reference product by a pharmacist without requiring approval or intervention from the prescribing healthcare provider.[4]
The proposed legislation would largely eliminate this distinction by amending the Public Health Service Act to provide that a biological product licensed under Section 351(k) shall be deemed interchangeable with its reference product. Supporters of the legislation argue the existing interchangeability requirements create unnecessary regulatory hurdles that can impede biosimilar adoption and competition.[5] In July 2025, 39 organizations joined the Biosimilars Council and Association for Accessible Medicines in supporting the Biosimilar Red Tape Elimination Act, and more than three dozen organizations reiterated their support in January 2026.[6]
Potential Impact on Biologics and Intellectual Property
Although the proposed legislation focuses on FDA regulation rather than U.S. patent law, it could have important implications for intellectual property strategy. The BPCIA also establishes specialized procedures for resolving certain patent disputes between biosimilar applicants and reference-product sponsors. Litigation under this framework may involve patents covering the biological product, formulations, methods of treatment, manufacturing processes, and other aspects of the product.
Further, biosimilar manufacturers must navigate patent rights associated with reference biologics before bringing competing products to market. Removing a separate regulatory hurdle for interchangeability could increase the commercial significance of these patent disputes. If a biosimilar can obtain interchangeable status without satisfying more onerous interchangeability requirements, patent disputes may become increasingly important in determining the timing and value of biosimilar market entry. Patent owners and biosimilar manufacturers may therefore place even greater emphasis on portfolio development, freedom-to-operate analyses, BPCIA litigation strategy, and the timing of patent challenges.
The legislation remains pending, but its progress warrants attention from both biologics innovators and biosimilar manufacturers. Streamlining interchangeability could reduce regulatory barriers to biosimilar competition while leaving patent protections and the existing BPCIA litigation framework intact. Therefore, careful coordination of regulatory and intellectual property strategies may become increasingly important as biosimilar competition expands.
Editor: Brenden S. Gingrich, Ph.D.
[1] In July 2026, the Senate HELP Committee reported an amended version of S. 1954 making several technical and clarifying changes.
[2] Commemorating the 15th Anniversary of the Biologics Price Competition and Innovation Act, FDA (Mar. 26, 2025), https://www.fda.gov/drugs/cder-conversations/commemorating-15th-anniversary-biologics-price-competition-and-innovation-act.
[3] Public Health Service Act § 351(k)(4), 42 U.S.C. § 262(k)(4) (2022). The requirement for switching studies is facing ongoing scrutiny. On June 20, 2024, the FDA issued draft guidance that instead recommends that “applicants for proposed interchangeable products may choose to provide an assessment of why the comparative analytical and clinical data provided in the application or supplement support a showing that the switching standard set forth in section 351(k)(4)(B) of the PHS Act has been met.” Considerations in Demonstrating Interchangeability With a Reference Product: Update, FDA (Jun. 20, 2024), https://www.fda.gov/regulatory-information/search-fda-guidance-documents/considerations-demonstrating-interchangeability-reference-product-update.
[4] 9 Things to Know About Biosimilars and Interchangeable Biosimilars, FDA (Oct. 26, 2026), https://www.fda.gov/drugs/biosimilars/9-things-know-about-biosimilars-and-interchangeable-biosimilars.
[5] See Over Three Dozen Groups Join the Biosimilars Council and AAM to Reiterate Support for Interchangeability Legislation, Biosimilars Council (Jan. 22, 2026), https://biosimilarscouncil.org/news/over-three-doze-groups-joins-biosimilars-council-aam-support-interchangeability-legislation/; Driving Access to Affordable Drugs – Streamlining Biosimilar Interchangeability Requirements, The ERISA Indus. Comm., https://www.eric.org/streamlining-biosimilar-interchangeability-requirements/ (referring to the requirements as “overly complex”).
[6] Over Three Dozen Groups Join the Biosimilars Council and AAM to Reiterate Support for Interchangeability Legislation, supra note 4; Groups Join the Biosimilars Council and AAM Letter of Support for Interchangeability Legislation, Ass’n for Accessible Meds. (July 8, 2025), https://accessiblemeds.org/resources/press-releases/groups-join-biosimilars-council-aam-letter-support-interchangeability-legislation/.
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