[Congressional Bills 118th Congress]
[From the U.S. Government Publishing Office]
[S. 2305 Introduced in Senate (IS)]
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118th CONGRESS
1st Session
S. 2305
To improve the requirements for making a determination of
interchangeability of a biological product and its reference product.
_______________________________________________________________________
IN THE SENATE OF THE UNITED STATES
July 13, 2023
Mr. Lee (for himself, Mr. Lujan, Mr. Braun, and Mr. Vance) introduced
the following bill; which was read twice and referred to the Committee
on Health, Education, Labor, and Pensions
_______________________________________________________________________
A BILL
To improve the requirements for making a determination of
interchangeability of a biological product and its reference product.
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 ``Biosimilar Red Tape Elimination
Act''.
SEC. 2. BIOSIMILAR BIOLOGICAL PRODUCTS.
(a) In General.--Section 351(k) of the Public Health Service Act
(42 U.S.C. 262(k)) is amended--
(1) in the subsection heading, by striking ``or
Interchangeable'';
(2) in paragraph (2)--
(A) by striking subparagraph (B);
(B) by redesignating clauses (ii) and (iii) of
subparagraph (A) as subparagraphs (B) and (C),
respectively, and adjusting the margins accordingly;
(C) in subparagraph (A)--
(i) in clause (i), by redesignating
subclauses (I) through (V) as clauses (i)
through (v), respectively, and adjusting the
margins accordingly;
(ii) in clause (i), as so redesignated by
clause (i) of this subparagraph, by
redesignating items (aa) through (cc) as
subclauses (I) through (III), respectively, and
adjusting the margins accordingly; and
(iii) by striking ``(a) in general'' and
all that follows through ``An application
submitted under this subsection shall include
information'' and inserting the following:
``(A) In general.--An application submitted under
this subsection shall include information'';
(D) in subparagraph (B), as so redesignated by
subparagraph (C) of this paragraph, by striking
``clause (i)(I)'' and inserting ``subparagraph
(A)(i)''; and
(E) in subparagraph (C), as so redesignated by
subparagraph (C) of this paragraph, by redesignating
subclauses (I) through (III) as clauses (i) through
(iii), respectively, and by adjusting the margins
accordingly;
(3) by amending paragraph (4) to read as follows:
``(4) Interchangeability.--
``(A) In general.--A biological product licensed
under this subsection shall be deemed to be
interchangeable with the reference product.
``(B) Congressional briefing prior to certain study
requirements.--The Secretary may require the sponsor of
an application submitted under this section to conduct
a study to evaluate the risk, in terms of safety,
purity, or potency, of alternating or switching between
the use of the biological product that is the subject
of the application and the reference product, if,
before requiring such a study, the Secretary first
holds a private briefing with the chair and ranking
member of the Committee on Health, Education, Labor,
and Pensions of the Senate and the chair and the
ranking member of the Committee on Energy and Commerce
of the House of Representatives, to explain why such a
study is necessary for the biological product, what
information the Secretary expects such a study to
reveal, what alternatives to such study have been
considered, and why those alternatives are not
sufficient.'';
(4) by striking paragraph (6); and
(5) in paragraph (8)(D)--
(A) in clause (i), by striking ``class; and'' and
inserting ``class.'';
(B) by striking clause (ii); and
(C) by striking ``description of--'' and all that
follows through ``criteria that the Secretary'' and
inserting ``description of the criteria that the
Secretary''.
(b) Conforming Amendments.--
(1) Section 351(i)(3) of the Public Health Service Act (42
U.S.C. 262(i)(3)) is amended by striking ``that is shown to
meet the standards described in subsection (k)(4)'' and
inserting ``licensed under subsection (k)''.
(2) Section 352A of the Public Health Service Act (42
U.S.C. 263-1) is amended by striking ``and interchangeable
biosimilar biological products'' each place it appears.
(3) Section 744G(14) of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 379j-51(14)) is amended by striking ``,
including a supplement requesting that the Secretary determine
that the biosimilar biological product meets the standards for
interchangeability described in section 351(k)(4) of the Public
Health Service Act''.
(4) By amending subsection (l) of section 505B of the
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355c) to read
as follows:
``(l) Biosimilar Biological Products.--A biological product for
which an application is submitted under section 351(k) of the Public
Health Service Act shall be considered to have a new active ingredient
for purposes of this section, except that a pediatric assessment shall
not be required for a claimed indication in a relevant pediatric
population if the assessment would involve--
``(1) a condition of use that has not been previously
approved for the reference product; or
``(2) a dosage form, strength, or route of administration
that differs from that of the reference product.''.
(c) Application.--The amendments made by subsection (a)(4) to
section 351(k)(6) of the Public Health Service Act (42 U.S.C.
262(k)(6)) shall apply only with respect to applications approved under
section 351(k) of such Act on or after the date of enactment of this
Act. Any period of exclusivity granted under section 351(k)(6) of such
Act with respect to an application approved under such section 351(k)
before the date of enactment of this Act shall apply in accordance with
such section 351(k)(6), as in effect on the day before the date of
enactment of this Act.
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