A bill to amend the Public Health Service Act to streamline the review of biosimilar biological products.
The source supplies the latest action, but no lifecycle stage.
Latest action (21 Jul 2026): Read twice and referred to the Committee on Health, Education, Labor, and Pensions.
What this bill does
S. 5059 would amend the Public Health Service Act's provisions governing biosimilar biological products, specifically the section addressing FDA review procedures for these products. The bill removes one subparagraph from the existing statute and renumbers the remaining subparagraph accordingly. Based on the text provided, the specific substantive requirement being eliminated is not described in detail, though the bill's title indicates its purpose is to streamline the FDA's review process for biosimilars—drugs that are highly similar to already-approved biological products.
The bill would primarily affect the Food and Drug Administration's internal review procedures for biosimilar applications, as well as pharmaceutical and biotechnology companies seeking approval to market biosimilar products. By removing a statutory provision, the bill could change timelines, requirements, or steps currently mandated in the biosimilar approval pathway, though the text excerpt does not specify what practical effect this removal would have on manufacturers, patients, or the broader market for biosimilars.
The bill was introduced in the Senate on July 21, 2026, by Senator Ashley Moody with three cosponsors, and has been referred to the Senate Committee on Health, Education, Labor, and Pensions for consideration. As a newly introduced bill, it would need to be reviewed and potentially amended by the committee, then pass both the Senate and House of Representatives, and be signed by the President before becoming law. No further action has yet been taken.
Plain-English summary generated by Bill100 AI from the official record. Always verify against the source below.
Timeline
21 Jul 2026
Read twice and referred to the Committee on Health, Education, Labor, and Pensions.
Common questions
- What does S. 5059 do?
- S. 5059 would amend the Public Health Service Act's provisions governing biosimilar biological products, specifically the section addressing FDA review procedures for these products. The bill removes one subparagraph from the existing statute and renumbers the remaining subparagraph accordingly. Based on the text provided, the specific substantive requirement being eliminated is not described in detail, though the bill's title indicates its purpose is to streamline the FDA's review process for biosimilars—drugs that are highly similar to already-approved biological products. The bill would primarily affect the Food and Drug Administration's internal review procedures for biosimilar applications, as well as pharmaceutical and biotechnology companies seeking approval to market biosimilar products. By removing a statutory provision, the bill could change timelines, requirements, or steps currently mandated in the biosimilar approval pathway, though the text excerpt does not specify what practical effect this removal would have on manufacturers, patients, or the broader market for biosimilars. The bill was introduced in the Senate on July 21, 2026, by Senator Ashley Moody with three cosponsors, and has been referred to the Senate Committee on Health, Education, Labor, and Pensions for consideration. As a newly introduced bill, it would need to be reviewed and potentially amended by the committee, then pass both the Senate and House of Representatives, and be signed by the President before becoming law. No further action has yet been taken.
- Has S. 5059 become law?
- The source does not supply a confirmed lifecycle stage for S. 5059. Check the latest action and official source below.
- Who sponsored S. 5059?
- S. 5059 was sponsored by Sen. Moody, Ashley [R-FL] (R-FL), with 3 cosponsors.
- What's the latest action on S. 5059?
- Read twice and referred to the Committee on Health, Education, Labor, and Pensions. (21 Jul 2026).
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