Expedited Access to Biosimilars Act
- Sponsor
- Rep. Langworthy, Nicholas A. [R-NY-23]
- Committees
- Energy and Commerce Committee (primary)
- Last action
- Jul 14, 2026
Bottom line
The bill aims to accelerate biosimilar drug approvals by streamlining clinical study requirements and FDA review processes, potentially increasing patient access to more affordable medicines.
What it actually does
This bill amends the Public Health Service Act to clarify that the Food and Drug Administration (FDA) should not automatically require extensive clinical studies assessing pharmacodynamics or comparative clinical efficacy for biosimilar drug approval. Instead, the FDA must specifically determine such studies are necessary to demonstrate biosimilarity and provide a written justification within strict timelines. It also repeals a specific requirement for the FDA to review public information about reference products for differences relevant to safety, purity, and potency.
Proponents argue
Proponents argue that the bill will reduce the time and cost associated with developing biosimilar drugs by eliminating redundant clinical trial requirements, thereby speeding up market entry and increasing competition. This, they contend, will lead to lower drug prices and improved access to critical biological therapies for patients, aligning the regulatory process with current scientific understanding of biosimilarity.
Opponents contend
Opponents might express concerns that reducing clinical study requirements could potentially compromise the rigor of the biosimilar approval process, leading to questions about the safety and efficacy of approved biosimilars. They may argue that robust comparative clinical data is essential to ensure patient confidence and to fully understand any subtle differences between a biosimilar and its reference product.
The bill text is short and focused, making it accessible for a quick read. However, understanding its full implications requires some familiarity with biosimilar regulation.
Section 2(a), amending 42 U.S.C. 262(k)(2)(A)
Codifying Default Expectation Against Certain Clinical Studies for Biosimilar Licensure
This provision clarifies that when a company seeks approval for a biosimilar drug, the FDA should not automatically require extensive clinical trials to assess how the drug affects the body (pharmacodynamics) or how well it works compared to the original drug (comparative clinical efficacy). Instead, the FDA must specifically determine such studies are necessary to prove biosimilarity and provide a written explanation early in the development process, either at the biosimilar product development meeting or within 60 days of application submission.
Supporters argue
Supporters argue this provision streamlines the biosimilar approval pathway, reducing unnecessary burdens on manufacturers and accelerating patient access to more affordable, life-saving medications. They contend that current scientific understanding and FDA's 'totality of the evidence' approach often make these extensive clinical studies redundant for demonstrating biosimilarity.
Critics contend
Critics may contend that this provision could weaken the rigor of the biosimilar approval process by reducing the default expectation for certain clinical studies. They might argue that pharmacodynamic and comparative efficacy data are crucial for fully assuring the safety and effectiveness of biosimilars, especially for complex biological products, and that reducing these requirements could erode public confidence.
Tradeoffs
This provision balances the desire for faster, more affordable access to biosimilars against concerns about maintaining the highest standards of safety and efficacy. It shifts the burden of proof to the FDA to justify additional studies, rather than having them as a potential default, which could either optimize resource allocation or create regulatory gaps.
Section 2(b), amending 42 U.S.C. 262(k)(5)
Repeal of Specific Review Requirement for Reference Product Differences
This provision removes a specific requirement for the FDA to conduct a review of all public information regarding the reference product (the original biologic drug) and to determine if there are any differences relevant to the safety, purity, and potency of the proposed biosimilar. This particular review step is eliminated from the biosimilar application process.
The bill repeals subparagraph (B) of Section 351(k)(5) of the Public Health Service Act, which required the Secretary to conduct a review of all public information regarding the reference product and determine any relevant differences with the biosimilar.
Section 2(b), amending 42 U.S.C. 262(k)(5)
Why it matters:This is a technical amendment to an existing statute. While consequential, the legislative drafting style for such changes often involves direct statutory modification rather than extensive explanation within the bill itself. It is standard legislative practice for statutory amendments.
Case for: Proponents argue that this specific review is redundant given the comprehensive data required for biosimilarity and the FDA's existing 'totality of the evidence' approach. Its removal streamlines the review process without compromising the scientific rigor of biosimilar approval, allowing the FDA to focus resources more efficiently.
Case against: Critics might suggest that removing any specific review requirement, even if seemingly redundant, could reduce the overall scrutiny applied during the biosimilar approval process. They may argue that every safeguard, including a dedicated review of reference product differences, contributes to ensuring patient safety and confidence.
Estimated impact: This change is expected to have a minor but positive impact on the efficiency of the FDA's biosimilar review process, potentially contributing to slightly faster approvals.