A bill to amend the Public Health Service Act to streamline the review of biosimilar biological products.
- Sponsor
- Sen. Moody, Ashley [R-FL]
- Committees
- Health, Education, Labor, and Pensions Committee (primary)
- Last action
- Jul 21, 2026
Bottom line
This bill simplifies the regulatory review process for biosimilar biological products by eliminating a specific statutory requirement, aiming to expedite their availability and foster market competition.
What it actually does
This bill amends the Public Health Service Act by removing a specific subparagraph (B) from Section 351(k)(5), which outlines the requirements for applications for biosimilar biological products. The change aims to streamline the regulatory pathway for these products by eliminating a particular statutory requirement, potentially accelerating their approval and market entry.
Proponents argue
Supporters argue that removing unnecessary bureaucratic hurdles will accelerate the availability of biosimilar products, increasing competition in the pharmaceutical market, lowering drug costs for consumers, and expanding patient access to critical medicines. They contend that the specific requirement being removed is either redundant or overly burdensome without providing commensurate safety or efficacy benefits.
Opponents contend
Opponents might contend that removing any part of the review process, even if intended for streamlining, could inadvertently compromise patient safety or the rigorous standards required for biological products. They may argue that thorough review ensures product integrity and public trust, and that any perceived delays are necessary safeguards to protect public health.
The bill text is extremely short and can be read in seconds, making it highly accessible for quick review by any interested party.
Section 1, "STREAMLINING BIOSIMILAR REVIEWS."
Amendment to Public Health Service Act Section 351(k)(5)
This provision directly amends the Public Health Service Act, specifically section 351(k)(5), which governs the review and approval process for biosimilar biological products. It achieves this by striking subparagraph (B) and subsequently renumbering subparagraph (C) as (B). The practical effect is to remove a specific requirement or condition from the existing regulatory framework that biosimilar applicants must meet, thereby simplifying the pathway for their approval by the Food and Drug Administration (FDA).
Supporters argue
Supporters argue that this specific amendment targets an unnecessary or redundant step in the biosimilar review process that does not contribute meaningfully to safety or efficacy oversight. Its removal will cut red tape, allowing innovative biosimilar products to reach patients more quickly and efficiently, fostering a more competitive market and driving down drug prices.
Critics contend
Critics might argue that even a seemingly minor removal from the review process could open unforeseen loopholes or reduce the robustness of the FDA's oversight. They may contend that every existing subparagraph serves a purpose in ensuring the safety, purity, and potency of biosimilars compared to their reference products, and its removal could introduce risks or diminish public confidence.
Tradeoffs
This provision navigates the tension between the desire for regulatory efficiency and faster market access for biosimilars on one hand, and the imperative to maintain stringent safety and efficacy standards for biological products on the other. The tradeoff involves balancing the potential for quicker drug availability and cost savings against the perceived rigor of the FDA's approval process.