A substantive restructuring of data requirements for biosimilar licensure. v2 refines the conditions under which the Secretary can require specific clinical studies for biosimilar approval, explicitly including immunogenicity assessment in standard requirements while establishing a formal procedure for requiring pharmacodynamics or efficacy studies. It also streamlines biosimilar reviews by deleting an existing subparagraph from the Public Health Service Act.
Expedited Access to Biosimilars Act
- Sponsor
- Sen. Paul, Rand [R-KY]
- Committees
- Health, Education, Labor, and Pensions Committee (primary)
- Last action
- Jul 27, 2026
Bottom line
The bill aims to streamline biosimilar approval by formalizing FDA's clinical study requirements for pharmacodynamics and efficacy, while explicitly mandating immunogenicity assessment and expanding FDA's authority for postmarket safety monitoring.
What it actually does
This bill, the "Expedited Access to Biosimilars Act," amends the Public Health Service Act to modify the clinical study requirements for biosimilar biological products. It mandates the assessment of pharmacokinetics and immunogenicity for biosimilar licensure. It also establishes a formal procedure for the Food and Drug Administration (FDA) to require additional clinical studies assessing pharmacodynamics or efficacy, mandating a written determination of necessity and strict rules for amending such requirements. Furthermore, the bill removes a previous restriction on the FDA, allowing it to require postmarket safety studies for biosimilars without first identifying a specific safety signal.
Proponents argue
Proponents argue that by formalizing the FDA's process for requiring specific clinical studies, the bill creates greater predictability and transparency for biosimilar developers, potentially accelerating market entry for these cost-saving drugs. They might also contend that explicitly requiring immunogenicity assessment, while providing flexibility in how it's met, ensures patient safety without undue burden. The expanded postmarket authority could be framed as a measure to ensure ongoing safety surveillance, building public trust in biosimilars.
Opponents contend
Opponents might argue that while the bill aims to expedite access, the explicit mandate for immunogenicity assessment and the expanded postmarket study authority could still pose significant hurdles or costs for biosimilar developers, potentially slowing market entry rather than accelerating it. Critics might also raise concerns that the procedural requirements for FDA to justify additional clinical studies could inadvertently create loopholes or delays in ensuring robust biosimilarity demonstrations, potentially impacting patient safety or confidence.
The bill is short and focused, but its technical nature and the nuances of its amendments to existing law mean that a careful reading is required to fully grasp its implications, especially regarding the changes from the original bill.
Section 2(a)(1)(B), inserting new clause (i)(I)(cc) into 42 U.S.C. 262(k)(2)(A).
Required Immunogenicity Assessment for Biosimilar Licensure
This provision requires that applications for biosimilar biological products must include an assessment of pharmacokinetics (how the body affects the drug) and immunogenicity (the body's immune response to the drug). It clarifies that this assessment can rely on or consist of other clinical pharmacokinetics studies already required. This makes immunogenicity assessment a mandatory component of biosimilar approval, albeit with flexibility in its execution.
Supporters argue
Supporters argue that explicitly requiring immunogenicity assessment ensures a consistent standard for biosimilar safety, addressing potential concerns about immune responses that could affect efficacy or cause adverse events. The flexibility to use existing pharmacokinetic studies prevents redundant testing.
Critics contend
Some might argue that mandating immunogenicity assessment for all biosimilars, even when not scientifically justified for certain products, could add unnecessary costs and time to the development process, potentially delaying patient access to more affordable biosimilars.
Tradeoffs
This provision balances the desire for expedited biosimilar access with the need to ensure patient safety regarding potential immune reactions. The tension lies in whether a universal mandate is always scientifically necessary or if it could create an undue burden.
Section 2(a)(1)(B), inserting new clause (i)(I)(dd) and Section 2(a)(2)(C), inserting new subclause (II) into 42 U.S.C. 262(k)(2)(A).
Formalized FDA Determination Process for Efficacy and Pharmacodynamics Studies
This provision states that the FDA can only require clinical studies assessing pharmacodynamics (how the drug affects the body) or efficacy if it provides a written determination to the biosimilar sponsor. This determination must explicitly state why such studies are necessary to demonstrate biosimilarity. The bill sets strict timelines for the FDA to issue this determination (at development meetings or within 60 days of application submission) and makes it difficult for the FDA to amend these requirements later without sponsor agreement or a detailed scientific justification.
Section 2(b), amending Section 351(k)(5) of the Public Health Service Act.
Removal of Restriction on Postmarket Safety Studies
This provision strikes a previous clause that prohibited the FDA from requiring postmarket studies for biosimilar biological products unless an "identified safety signal" was present. By removing this restriction, the bill expands the FDA's authority, allowing it to require postmarket studies for biosimilars even without a pre-existing safety concern, potentially for broader surveillance or data collection purposes.
This section strikes subparagraph (B) from Section 351(k)(5) of the Public Health Service Act. Subparagraph (B) previously stated: "The Secretary may not require a postmarket study or studies for a biosimilar biological product unless the Secretary determines that such a study or studies are necessary to assess an identified safety signal." Its removal means the FDA is no longer restricted to only requiring postmarket studies when a safety signal has already been identified.
Section 2(b)
Why it matters:While deletions are common legislative practice, placing this under "Streamlining Biosimilar Reviews" might be seen as potentially evasive, as the effect of this specific deletion is to expand FDA's regulatory power, which could increase burden on manufacturers, rather than streamline.
Case for: Proponents (likely FDA and patient safety groups) argue that removing this restriction gives the FDA greater flexibility to conduct proactive safety surveillance and gather more comprehensive real-world data on biosimilars, enhancing patient safety and public confidence.
Case against: Biosimilar manufacturers might argue that this expanded authority could lead to arbitrary or excessive postmarket study requirements, increasing costs and uncertainty for approved products, thereby hindering biosimilar market growth and access.
Estimated impact: This change could lead to increased post-market surveillance costs for biosimilar manufacturers, potentially affecting the profitability and market entry of biosimilar products. It also provides the FDA with a broader toolset for ensuring long-term product safety.