[Congressional Bills 118th Congress]
[From the U.S. Government Publishing Office]
[S. 2305 Introduced in Senate (IS)]

<DOC>






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.
                                 <all>