HouseH.R. 9661119th Congress
Expedited Access to Biosimilars Act
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[Congressional Bills 119th Congress]
[From the U.S. Government Publishing Office]
[H.R. 9661 Introduced in House (IH)]
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119th CONGRESS
2d Session
H. R. 9661
To amend the Public Health Service Act to codify that the default
expectation for licensure of biological products as biosimilar does not
include clinical studies assessing pharmacodynamics or comparative
clinical efficacy, and for other purposes.
_______________________________________________________________________
IN THE HOUSE OF REPRESENTATIVES
July 14, 2026
Mr. Langworthy (for himself and Ms. Schrier) introduced the following
bill; which was referred to the Committee on Energy and Commerce
_______________________________________________________________________
A BILL
To amend the Public Health Service Act to codify that the default
expectation for licensure of biological products as biosimilar does not
include clinical studies assessing pharmacodynamics or comparative
clinical efficacy, and for other purposes.
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 PHARMACODYNAMICS OR 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)--
(i) by striking ``item (aa) or (cc)'' and
inserting ``item (aa), (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 or a study or studies
described in item (aa) or (dd),
as appropriate); and
``(dd) subject to clause
(iv), an additional clinical
study or studies 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) Limitation on requiring additional
clinical study or studies.--The Secretary may
only require an additional clinical study or
studies described in clause (i)(I)(dd),
including a study or studies that include an
assessment of pharmacodynamics or efficacy, if
the Secretary determines that such study or
studies are necessary, in combination with the
other studies described in clause (i)(I), to
demonstrate biosimilarity and provides written
notice of such determination to the sponsor of
the proposed biosimilar biological product.
Such written notice shall be provided not later
than--
``(I) the date on which the
Secretary grants a request for a
biosimilar biological product
development meeting from such sponsor,
unless the Secretary describes in
writing why an assessment of the need
for such study or studies cannot be
made at that time; or
``(II) if no request for a
biosimilar biological product
development meeting is submitted or if
the Secretary was unable to make the
assessment under subclause (I), the
date that is 60 days after the date of
the submission of an application under
this subsection.''.
(b) Repeal of Requirement Relating To Conduct of 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 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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