Driving Access to Affordable Drugs - Streamlining Biosimilar Interchangeability Requirements

Biosimilars offer safe, effective, and lower-cost alternatives to brand-name biologic medications, yet overly complex interchangeability requirements have slowed their widespread adoption. Simplifying these regulatory hurdles will empower pharmacists and providers to more readily substitute biosimilars, increasing competition and delivering savings to patients, employers, and health plans alike.

  • Biosimilar Red Tape Elimination Act (S. 1954 and H.R. 5526)
    • This bill removes certain requirements for biosimilars to be designated as interchangeable. Specifically, it establishes a presumption that an approved biosimilar is interchangeable with the reference product without the need for additional evidence from the manufacturer, and it removes the applicable exclusivity periods for a first interchangeable biosimilar. The FDA may require a manufacturer of a biosimilar to conduct a safety study with respect to switching or alternating between the biosimilar and the reference product, but only after the FDA briefs certain members of specified congressional committees to explain why the study is necessary.
  • Lee Bill Cuts Drug Prices and Red Tape (06.04.2025)
    • Senators introduced the legislation  which would immediately deem FDA-approved biosimilars as interchangeable with their brand-name counterparts—eliminating redundant “switching study” requirements—to streamline approval, boost competition, and reduce drug prices. Supporters emphasize that this will empower pharmacists to substitute lower-cost biosimilars, potentially saving consumers billions while upholding safety standards.
  • Rep. Pfluger Introduces Bill to Lower Prescription Drug Prices for Texans (09.10.2025)
    • This press release explains that would improve patient access to lower-cost prescription medications and increase competition in the biological drug market by automatically deeming “biosimilar” drugs as interchangeable with their name-brand counterparts upon FDA approval.
  • One-Pager on S. 1954
    • The bill aims to lower drug costs by eliminating the FDA’s burdensome “interchangeability” designation for biosimilars, which has created confusion and restricted pharmacist substitution. The bill would automatically deem all FDA-approved biosimilars as interchangeable, eliminate costly switching study requirements, and align U.S. policy with international scientific consensus showing no added risk from switching—ultimately streamlining access, promoting competition, and generating billions in potential savings.
  • FTC/DOJ Listening Session on Lowering Drug Prices
    • The first listening session, “Lowering Americans’ Drug Prices Through Competition”, focused on anticompetitive conduct related to patent abuses (e.g. patent thickets), regulatory approval obstacles (e.g., interchangeability standards), and PBM practices. ERIC’s President and CEO, James Gelfand, participated in the listening session and presented information on the importance of generics and biosimilars to help lower overall drug spending by employer plans and employees. In his remarks, he discussed PBM rebating practice, the need to get rid of interchangeability standards, and patent trolling. He pointed out several bills that ERIC supports in Congress to improve the market and how best to work with the agencies.
  • ERIC Statement on Trump Administration Announcement to Accelerate Biosimilar Development and Lower Drug Costs
    • The ERISA Industry Committee (ERIC) issued the following statement today regarding the Trump Administration’s announcement to make it faster and less costly to develop biosimilar medicines.
  • Labeling for Biosimilar and Interchangeable Biosimilar Products; Guidance for Industry DRAFT GUIDANCE (FDA-2016-D-0643)
    • ERIC comments to FDA appreciating the withdrawal of guidance specifying that an interchangeability statement be included in the labeling of products licensed as interchangeable. This signals a positive step towards ensuring competition and access to biosimilars.
  • Considerations in Demonstrating Interchangeability with a Reference Product: Update; Draft Guidance for Industry [Docket No. FDA-2017-D-0154]
    • ERIC applauds the FDA for recognizing the switching study requirement as a hurdle which delays and prevents competition. Removal of the switching study requirement does not compromise safety, efficacy, or quality.
  • More information on biosimilars cost savings and competition
    • ERIC’s research on expanding access to biosimilars has been shown to significantly lower drug spending and increase market competition, reinforcing the need for streamlined policies that facilitate their use.