Expedited Access to Biosimilars Act
Latest action (Jul 27, 2026) — under General Orders. Calendar No. 520.
What it does
Congressional Research Service, Jul 27, 2026This bill modifies statutory requirements for demonstrating that a proposed biological product (e.g., a drug or vaccine) is biosimilar to a reference (brand-name) product. Specifically, the bill eliminates the need for a clinical efficacy study unless the Food and Drug Administration (FDA) determines such a study is necessary.
Under current law, applicants seeking FDA approval of a proposed biosimilar must submit certain studies and assessments, including a clinical efficacy study demonstrating the safety, purity, and potency of the proposed biosimilar in relevant conditions of use. However, the FDA has discretion not to require studies and assessments it deems unnecessary. (For example, the FDA released draft guidance in October 2025 indicating that clinical efficacy studies may be unnecessary for a class of proposed biosimilars, known as therapeutic protein products, in some circumstances.)
The bill generally eliminates the requirement that a biosimilar applicant submit a clinical efficacy study but authorizes the FDA to require such a study if necessary. If requiring a clinical efficacy study, the FDA must provide a written determination of necessity to the applicant within a specified period.
Separately, the bill eliminates a requirement that a biosimilar application be reviewed by the same FDA division responsible for review of the reference application.
Face Value
as reported to the SenateHow much of this bill its name accounts for.
- Every bill starts at100
- Nothing counted against it: one area of law, and short enough that length doesn't register.
Face Value measures reach, not honesty. A big bill can be accurately named, and a low score is not an accusation — it means the contents reach further than any short title could describe. Count it yourself ↗ How this is worked out
Who lobbied on this
5 organizationsThese organizations told Congress, in their own quarterly disclosures, that they were lobbying on this bill.
- America's Health Insurance Plans, Inc.no position stated
“…Klobuchar, Amy - Drug patent reform S. 1096 - Preserve Access to Affordable Generics and Biosimilars Act - Sen. Klobuchar, Amy - Drug patent reform S. 1414 - Expedited Access to Biosimilars Act - Sen. Paul, Rand - Biosimilars assessment and approval S. 1587 - Fair Prescription Drug Prices for…” filing ↗
- Amgen Inc.no position stated
“…Act for Fiscal year 2027 HR 9102 BINSA Bill COINS Act, enacted within P.L. 119-60 National Defense Authorization Act for Fiscal Year 2026 S 1414 Expedited Access to Biosimilars Act” filing ↗
- Biotechnology Innovation Organizationno position stated
“…---Reauthorization of Pandemic and All-Hazards Preparedness and Advancing (PAHPA) ---Risky Research Review Act ---VICP Loopholes Biosimilars ---S.1414: Expedited Access to Biosimilars Act ---Biosimilars Competition (General) ---Biosimilar Red Tape Elimination Act ---Interchangeability and…” filing ↗
- Pharmaceutical Care Management Associationno position stated
“…Interagency Patent Coordination and Improvements Act of 2025 S.…” filing ↗
- Pharmaceutical Research & Manufacturers of Americano position stated
“…Act S. 891: Bipartisan Health Care Act (including section 227 - Modernizing and Ensuring PBM Accountability) S. 932: Give Kids a Chance Act of 2025 S. 1414: Expedited Access to Biosimilars Act S. 1954: Biosimilar Red Tape Elimination Act S. 2296: BIOSECURE Act (S.Amdt. 3236 to National Defense…” filing ↗
Most filings say only that an organization lobbied on a bill, not which side it took — where that's the case we say so rather than guessing. Quotes are verbatim from the filing. How this is built.
Discussion
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