What does Preamble of Biosimilar Red Tape Elimination Act do?

This bill aims to improve the requirements for determining the interchangeability of a biological product and its reference product.

What does SHORT TITLE. of Biosimilar Red Tape Elimination Act do?

This bill is formally titled the Biosimilar Red Tape Elimination Act

What does BIOSIMILAR BIOLOGICAL PRODUCTS. of Biosimilar Red Tape Elimination Act do?

This section amends Section 351(k) of the Public Health Service Act to modify requirements related to biosimilar biological products and interchangeability. It redesignates and adjusts clauses and subclauses within the existing text of Section 351(k) to streamline language and structure. The bill establishes a 'transition date,' 60 days after enactment, impacting when a biological product is deemed interchangeable. It clarifies the timing of deemed interchangeability for biological products licensed before and after the transition date, considering existing exclusivity periods. The bill modifies provisions related to first interchangeable exclusivity periods. It makes conforming amendments to other sections of the Public Health Service Act and the Federal Food, Drug, and Cosmetic Act. The Secretary is directed to update guidance documents related to biosimilar biological products within 18 months of the Act's enactment. The amendments are not intended to alter the standard for biosimilar licensure or limit the information the Secretary may require.

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Biosimilar Red Tape Elimination Act

Last updated: 9/19/2025 · Introduced: 9/19/2025

Author: August Pfluger (R-TX)

TL;DR (AI)

The bill modifies requirements for determining the interchangeability of a biological product and its reference product under Section 351(k) of the Public Health Service Act.
It establishes a transition date, 60 days after enactment, which affects when a biological product is deemed interchangeable, considering existing exclusivity periods.
The bill directs the Secretary to update guidance documents related to biosimilar biological products within 18 months of the Act's enactment.

119th Congressin committeeS. 1954(In Committee)Official page

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Other Sections

Includes provisions on preamble, short title., and 1 more.

3 sections

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