[Congressional Bills 119th Congress]
[From the U.S. Government Publishing Office]
[S. 1414 Reported in Senate (RS)]
<DOC>
Calendar No. 520
119th CONGRESS
2d 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 (for himself, Mr. Lee, and Ms. Hassan) introduced the
following bill; which was read twice and referred to the Committee on
Health, Education, Labor, and Pensions
July 27, 2026
Reported by Mr. Cassidy, with an amendment
[Strike out all after the enacting clause and insert the part printed
in italic]
_______________________________________________________________________
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,
<DELETED>SECTION 1. SHORT TITLE.</DELETED>
<DELETED> This Act may be cited as the ``Expedited Access to
Biosimilars Act''.</DELETED>
<DELETED>SEC. 2. ASSESSMENT OF IMMUNOGENICITY, PHARMACODYNAMICS, OR
COMPARATIVE CLINICAL EFFICACY IN CLINICAL STUDIES
REQUIRED FOR LICENSURE OF BIOLOGICAL PRODUCTS AS
BIOSIMILAR.</DELETED>
<DELETED> (a) In General.--Section 351(k)(2)(A) of the Public Health
Service Act (42 U.S.C. 262(k)(2)(A)) is amended--</DELETED>
<DELETED> (1) in clause (i)(I)--</DELETED>
<DELETED> (A) in item (bb), by striking ``and'' at
the end; and</DELETED>
<DELETED> (B) by striking item (cc) and inserting
the following</DELETED>
<DELETED> ``(cc) a clinical
study or studies assessing
pharmacokinetics that are
sufficient to demonstrate
safety, purity, and potency;
and</DELETED>
<DELETED> ``(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</DELETED>
<DELETED> (2) by adding at the end the following:</DELETED>
<DELETED> ``(iv) Clinical studies.--
</DELETED>
<DELETED> ``(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.</DELETED>
<DELETED> ``(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.''.</DELETED>
<DELETED> (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.</DELETED>
SECTION 1. SHORT TITLE.
This Act may be cited as the ``Expedited Access to Biosimilars
Act''.
SEC. 2. DATA 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)--
(i) by striking ``or (cc)'' and inserting
``, (cc), or (dd)''; and
(ii) by striking ``and'' at the end; and
(B) by striking item (cc) and inserting the
following
``(cc) an assessment of
pharmacokinetics and
immunogenicity (which may rely
on, or consist of, a clinical
pharmacokinetics study or
studies described in item (aa)
or (dd)), as appropriate; and
``(dd) a clinical study or
studies, if required by the
Secretary pursuant to clause
(ii)(II), to support a
demonstration that there is no
clinically meaningful
difference between the
biological product and the
reference product in terms of
safety, purity, and potency of
such product;''; and
(2) in clause (ii)--
(A) in the clause heading, by striking
``Determination'' and inserting ``Determinations'';
(B) by striking ``The Secretary may'' and inserting
the following:
``(I) In general.--The Secretary
may''; and
(C) by adding at the end the following:
``(II) Procedure for certain
studies.--
``(aa) In general.--For an
application for licensure of a
biosimilar biological product
submitted under this
subsection, the Secretary may
require a clinical study that
includes an assessment of
pharmacodynamics or efficacy,
as described in clause
(i)(I)(dd), only if the
Secretary provides a written
determination, as described in
item (bb) or (cc), to the
sponsor of the biosimilar
biological product that such
assessments or studies are
necessary, in combination with
other information required
pursuant to clause (i)(I), to
demonstrate biosimilarity.
``(bb) Written
determination.--The Secretary
shall--
``(AA) when the
Secretary issues
meeting minutes of a
biosimilar biological
product development
meeting (as such term
is defined in section
744G(5) of the Federal
Food, Drug, and
Cosmetic Act), provide
a written determination
described in item (aa),
or provide written
notice to the sponsor
that describes why such
a determination can not
be made at such time;
and
``(BB) if the
Secretary is unable to
make a written
determination described
in item (aa) at the
time described in
subitem (AA), provide
such determination not
later than 60 days
after the date of
submission of an
application for
licensure under this
section.
``(cc) Amendment to a
determination.--A written
determination under this
subclause shall not be amended
to require a clinical study or
studies described in clause
(i)(I)(dd) after the date on
which such a determination is
made, except--
``(AA) by written
agreement with the
sponsor; or
``(BB) in the case
that the Secretary
determines there is a
scientific
justification to amend
the determination,
provides a detailed
written justification
to the sponsor as soon
as practicable, and,
upon the request of the
sponsor, holds a
biosimilar biological
product development
meeting (as such term
is defined in section
744G(5) of the Federal
Food, Drug, and
Cosmetic Act) to
discuss the
amendment.''.
(b) Streamlining Biosimilar Reviews.--Section 351(k)(5) of the
Public Health Service Act (42 U.S.C. 262(k)(5)) is amended--
(1) by striking subparagraph (B); and
(2) by redesignating subparagraph (C) as subparagraph (B).
(c) Applicability.--The amendments made by subsections (a) and (b)
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.
Calendar No. 520
119th CONGRESS
2d Session
S. 1414
_______________________________________________________________________
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.
_______________________________________________________________________
July 27, 2026
Reported with an amendment