YourVoice.Now Summary
Your MoneyCorporate BenefitsMakers of near-copies of brand-name biologic drugs could skip a head-to-head study unless FDA asked.
Your Money
Today a drugmaker must run a clinical study comparing its copy to the brand-name drug before FDA can approve it. Under the bill that study would happen only when FDA decides in writing that it is needed, though tests of how the drug behaves in the body and whether it sets off an immune response would stay required.
Corporate Benefits
FDA could still order a comparison study, but only by telling the company in writing why it is needed, either at a development meeting or within 60 days of filing. After that, FDA could add a study only with the company's agreement or a detailed written scientific reason.
More about this bill
Biosimilars are near-copies of complex brand-name drugs, such as some arthritis and cancer treatments. Today a company seeking approval must run a clinical study that compares its copy to the original. This bill would drop that as an automatic step. The study would be needed only when the Food and Drug Administration (FDA) decides in writing that it is. Tests of how the drug moves through the body would still be required. So would tests of whether it sets off an immune response. FDA would have to give its written reason at a drug development meeting, or within 60 days after a company applies. After that, it could add a study only with the company's agreement or a written scientific reason. The bill would also end the rule that the same FDA division which cleared the brand-name drug must review the copy. The changes would cover applications filed on or after the day it became law. The Senate has not voted on it.
Congressional Summary
Expedited Access to Biosimilars Act This 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 (For example, the FDA released draft guidance in October 2025 indicating that clinical efficacy studies may be unnecessary for a class of proposed biosimilars, known as therapeutic protein products, in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.
Legislative Subjects
Details
- Congress
- 119th
- Chamber
- Senate
- Status
- summarized
- Action
- Reported to Senate
- Action Date
- 2026-07-27
- Date Added
- 2026-09-15
- Source
- Congress.gov →
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