Bill speeds up FDA review of copy drugs called biosimilars.
S. 5059 — A bill to amend the Public Health Service Act to streamline the review of biosimilar biological products. · Filed by Ashley Moody (R-FL) · 3 cosponsors · Introduced Jul 21, 2026 · Referred to committee
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What it does
The bill removes one step from how the FDA checks biosimilar drugs. Biosimilar drugs are copies of expensive biologic drugs. The bill takes out subparagraph (B) from Section 351(k)(5). This is part of the Public Health Service Act. It renumbers what is left. The goal is to make FDA approval faster.
Who it affects
Patients who take expensive biologic drugs could be affected. Drug makers who create biosimilars could be affected. The FDA would follow a shorter review process.
One thing to notice
The bill text does not say what subparagraph (B) requires. Without that detail, it is unclear if the bill removes a safety check or a slow step.
From the analysis of the bill text, linked under Primary records below.
Where it stands
3 cosponsors: 2 Democrats, 1 Republicans.
- Jul 21, 2026 — Introduced · Congress.gov: “Introduced in Senate”
- Jul 21, 2026 — Referred to Senate Committee on Health, Education, Labor, and Pensions · Congress.gov: “Read twice and referred to the Committee on Health, Education, Labor, and Pensions”
Dates and quoted wording are Congress.gov's action record; the timeline shows status changes, not every procedural step.
Words to know
- biosimilar — A drug made to copy an expensive biologic drug.
- biologic — A medicine made from living cells or organisms.
- FDA — The Food and Drug Administration, which approves drugs in the U.S.
How this was measured
Analysis — Quorum's AI read the bill text published by Congress.gov (191 characters) on Jul 28, 2026. Section numbers in the findings refer to that text, linked below; transparency and hidden-provision scores are compared against the median of 14,206 analysed bills.
Status and sponsors — Congress.gov's bill record — actions, committee referrals and cosponsors — loaded nightly. The timeline shows status changes, not every procedural action.
As of — page rendered 2026-09-17.
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