U.S. Congress legislation · 119th Congress
SB1414: Expedited Access to Biosimilars Act
Status: In committee, July 27, 2026
A bill to amend the Public Health Service Act to provide that clinical studies required for licensure of biological products as biosimilar shall not be required to include the assessment of immunogenicity, pharmacodynamics, or comparative clinical efficacy.
What the bill says
To amend the Public Health Service Act to provide that clinical studies required for licensure of biological products as biosimilar shall not be required to include the assessment of immunogenicity, pharmacodynamics, or comparative clinical efficacy.
From the introduced text, July 27, 2026:
A BILL To amend the Public Health Service Act to provide that clinical studies required for licensure of biological products as biosimilar shall not be required to include the assessment of immunogenicity, pharmacodynamics, or comparative clinical efficacy. SECTION 1. Short title This Act may be cited as the Expedited Access to Biosimilars Act . SECTION 2. Assessment of immunogenicity, pharmacodynamics, or comparative clinical efficacy in clinical studies required for licensure of biological products as biosimilar (a) In general Section 351(k)(2)(A) of the Public Health Service Act ( 42 U.S.C. 262(k)(2)(A) ) is amended-- (1) in clause (i)(I)-- (A) in item (bb), by striking and at the end; and (B) by striking item (cc) and inserting the following (cc) a clinical study or studies assessing pharmacokinetics that are sufficient to demonstrate safety, purity, and potency; and (dd) subject to clause (iv), a clinical study or studies that are sufficient to demonstrate safety, purity, and potency in 1 or more appropriate conditions of use for which the reference product is licensed and intended to be used and for which licensure is sought for the biological product; ; and (2) by adding at the end the following: (iv) Clinical studies (I) In general Subject to subclause (II), the Secretary may determine, in the Secretary's discretion, that a clinical study required under clause (i)(I)(dd) …
Sponsors
- Paul, Rand (R) · primary sponsor
- Lee, Mike (R)
- Margaret Hassan (D, SD-NH)
Latest actions
- : Placed on Senate Legislative Calendar under General Orders. Calendar No. 520.
- : 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, Medical research, Health
Common questions
- What is SB1414?
- SB1414 is a bill in Congress (119th Congress): Expedited Access to Biosimilars Act.
- What does SB1414 do?
- In its own words: To amend the Public Health Service Act to provide that clinical studies required for licensure of biological products as biosimilar shall not be required to include the assessment of immunogenicity, pharmacodynamics, or comparative clinical efficacy.
- What is the status of SB1414?
- In committee as of July 27, 2026. Latest action: Placed on Senate Legislative Calendar under General Orders. Calendar No. 520. (July 27, 2026).
- Who sponsored SB1414?
- Paul, Rand (R), with 2 co-sponsors.
- Where is the official record for SB1414?
- On the Congress website: https://www.congress.gov/bill/119th-congress/senate-bill/1414
Source: official Congress record. Tracked by Delilah, AI for legislation across all 50 states and Congress.