3.0.0 2305 2025-05-27T14:16:16Z 2025-05-27T14:16:16Z Senate S S 2023-07-13 118 sshr00 Health, Education, Labor, and Pensions Committee Senate Standing Referred To 2023-07-13T17:57:31Z 2023-07-13 sshr00 Health, Education, Labor, and Pensions Committee Senate Read twice and referred to the Committee on Health, Education, Labor, and Pensions. IntroReferral 2023-07-13 Introduced in Senate IntroReferral 10000 9 Library of Congress L000577 Sen. Lee, Mike [R-UT] Mike Lee R UT N L000570 Sen. Lujan, Ben Ray [D-NM] Ben Lujan D NM R. 2023-07-13 True B001310 Sen. Braun, Mike [R-IN] Mike Braun R IN 2023-07-13 True V000137 Sen. Vance, J. D. [R-OH] J. Vance R OH D. 2023-07-13 True P000603 Sen. Paul, Rand [R-KY] Rand Paul R KY 2023-09-11 False Health Health 2023-08-23T17:30:25Z

00 2023-07-13 Introduced in Senate 2024-10-03T20:27:03Z <p><strong>Biosimilar Red Tape Elimination Act</strong></p><p>This bill removes certain requirements for biosimilars to be designated as interchangeable. (Biosimilars that are designated as interchangeable may be substituted for the reference product at a pharmacy without a new prescription, depending on state pharmacy laws.)</p><p>Specifically, the bill establishes a presumption that an approved biosimilar is interchangeable with the reference product without the need for additional evidence from the manufacturer, and it removes the applicable exclusivity periods for a first interchangeable biosimilar (i.e., a product that is the first interchangeable biosimilar to be approved with respect to the reference product).</p><p>The Food and Drug Administration (FDA) may require a manufacturer of a biosimilar to conduct a safety study with respect to switching or alternating between the biosimilar and the reference product, but only after the FDA briefs certain members of specified congressional committees to explain why the study is necessary.</p><p>&nbsp;</p>

Display Title 45 2024-07-24T15:21:04Z Short Title(s) as Introduced 101 2024-05-24T13:37:50Z Introduced in Senate IS Official Title as Introduced 6 2023-08-08T04:14:34Z Introduced in Senate IS Introduced in Senate 2023-07-13T04:00:00Z https://www.govinfo.gov/content/pkg/BILLS-118s2305is/xml/BILLS-118s2305is.xml 2023-07-13 Read twice and referred to the Committee on Health, Education, Labor, and Pensions. text/xml EN Pursuant to Title 17 Section 105 of the United States Code, this file is not subject to copyright protection and is in the public domain. Congressional Research Service, Library of Congress This file contains bill summaries and statuses for federal legislation. A bill summary describes the most significant provisions of a piece of legislation and details the effects the legislative text may have on current law and federal programs. Bill summaries are authored by the Congressional Research Service (CRS) of the Library of Congress. As stated in Public Law 91-510 (2 USC 166 (d)(6)), one of the duties of CRS is "to prepare summaries and digests of bills and resolutions of a public general nature introduced in the Senate or House of Representatives". For more information, refer to the User Guide that accompanies this file.