119-s1414

[Congressional Bills 119th Congress]
[From the U.S. Government Publishing Office]
[S. 1414 Introduced in Senate

    (IS) ]

<DOC>

119th CONGRESS
 1st Session
 S. 1414

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.

_______________________________________________________________________

 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.

 Be it enacted by the Senate and House of Representatives of the 
United States of America in Congress assembled,

SECTION 1. SHORT TITLE.

 This Act may be cited as the ``Expedited Access to Biosimilars 
Act''.

SEC. 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.
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