U.S. Congress legislation · 119th Congress
SB1954: Biosimilar Red Tape Elimination Act
Status: In committee, July 27, 2026
A bill to improve the requirements for making a determination of interchangeability of a biological product and its reference product.
What the bill says
To improve the requirements for making a determination of interchangeability of a biological product and its reference product.
From the introduced text, July 27, 2026:
A BILL To improve the requirements for making a determination of interchangeability of a biological product and its reference product. SECTION 1. Short title This Act may be cited as the Biosimilar Red Tape Elimination Act . SECTION 2. Biosimilar biological products (a) In general Section 351(k) of the Public Health Service Act ( 42 U.S.C. 262(k) ) is amended-- (1) in the subsection heading, by striking or interchangeable ; (2) in paragraph (2)-- (A) by striking subparagraph (B); (B) by redesignating clauses (ii) and (iii) of subparagraph (A) as subparagraphs (B) and (C), respectively, and adjusting the (l) Biosimilar biological products A biological product for which an application is submitted under section 351(k) of the Public Health Service Act shall not be considered to have a new active ingredient for purposes of this section, unless the application seeks licensure for-- (1) a claimed indication that has been approved for the reference product in a relevant pediatric population or for which there is a deferral of the pediatric assessment under paragraph (4) for the reference product; and (2) the assessment would not involve the development of a biological product with a strength, dosage form, route of administration, or condition of use that could not be licensed under section 351(k) of the Public Health Service Act. . (c) Guidance The Secretary …
Sponsors
- Lee, Mike (R) · primary sponsor
- Lujan, Ben Ray (D)
- Paul, Rand (R)
- Margaret Hassan (D, SD-NH)
- Schmitt, Eric (R)
- Ossoff, Jon (D)
Latest actions
- : Placed on Senate Legislative Calendar under General Orders. Calendar No. 521.
- : Committee on Health, Education, Labor, and Pensions. Reported by Senator Cassidy with an amendment in the nature of a substitute. Without written report.
- : Committee on Health, Education, Labor, and Pensions. Ordered to be reported with an amendment in the nature of a substitute favorably.
- : Introduced in Senate
- : Read twice and referred to the Committee on Health, Education, Labor, and Pensions.
Subjects: Licensing and registrations, Drug safety, medical device, and laboratory regulation, Government information and archives, Health, Prescription drugs
Common questions
- What is SB1954?
- SB1954 is a bill in Congress (119th Congress): Biosimilar Red Tape Elimination Act.
- What does SB1954 do?
- In its own words: To improve the requirements for making a determination of interchangeability of a biological product and its reference product.
- What is the status of SB1954?
- In committee as of July 27, 2026. Latest action: Placed on Senate Legislative Calendar under General Orders. Calendar No. 521. (July 27, 2026).
- Who sponsored SB1954?
- Lee, Mike (R), with 5 co-sponsors.
- Where is the official record for SB1954?
- On the Congress website: https://www.congress.gov/bill/119th-congress/senate-bill/1954
Source: official Congress record. Tracked by Delilah, AI for legislation across all 50 states and Congress.