S. 1414

119 S1414 IS: Expedited Access to Biosimilars Act
 U.S. Senate
 2025-04-10
 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.
 II  119th CONGRESS  1st Session  S. 1414  IN THE SENATE OF THE UNITED STATES   April 10, 2025   Mr. Paul  introduced the following bill; which was read twice and referred to the  Committee on Health, Education, Labor, and Pensions    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.
1.
Short title
This Act may be cited as the   Expedited Access to Biosimilars Act  .
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) shall include the assessment of immunogenicity, pharmacodynamics, or comparative clinical efficacy.
(II)
Requirement
The Secretary may only require the assessment of immunogenicity, pharmacodynamics, or comparative clinical efficacy pursuant to a determination under subclause (I) if the Secretary provides to the applicant notice of the requirement, including a written justification of the basis for such determination, not later than the earliest date on which the applicant may file the application under this subsection.
 .
(b)
Applicability
The amendments made by subsection (a) shall apply with respect to an application submitted under section 351(k) of the Public Health Service Act ( 42 U.S.C. 262(k) ) on or after the date of enactment of this Act.