I 
119TH CONGRESS 
1ST SESSION H. R. 5526 
To improve the requirements for making a determination of interchangeability 
of a biological product and its reference product. 
IN THE HOUSE OF REPRESENTATIVES 
SEPTEMBER 19, 2025 
Mr. PFLUGER (for himself and Mr. LANDSMAN) introduced the following bill; 
which was referred to the Committee on Energy and Commerce 
A BILL 
To improve the requirements for making a determination 
of interchangeability of a biological product and its ref-
erence product. 
Be it enacted by the Senate and House of Representa-
tives 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’’; 
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(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 ac-
cordingly; 
(C) in subparagraph (A)— 
(i) in clause (i), by redesignating sub-
clauses (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 redesig-
nating items (aa) through (cc) as sub-
clauses (I) through (III), respectively, and 
adjusting the margins accordingly; 
(iii) in subclause (II) of clause (i), as 
so redesignated by clause (ii) of this sub-
paragraph, by striking ‘‘item (aa) or (cc)’’ 
and inserting ‘‘subclause (I) or (III)’’; and 
(iv) by striking ‘‘(A) IN GENERAL’’ and 
all that follows through ‘‘An application 
submitted under this subsection shall in-
clude information’’ and inserting the fol-
lowing: 
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‘‘(A) IN
GENERAL.—An application sub-
mitted under this subsection shall include infor-
mation’’; 
(D) in subparagraph (B), as so redesig-
nated by subparagraph (B) of this paragraph, 
by striking ‘‘clause (i)(I)’’ and inserting ‘‘sub-
paragraph (A)(i)’’; and 
(E) in subparagraph (C), as so redesig-
nated by subparagraph (B) of this paragraph, 
by redesignating subclauses (I) through (III) as 
clauses (i) through (iii), respectively, and by ad-
justing the margins accordingly; 
(3) by amending subparagraph (A) of para-
graph (3) to read as follows: 
‘‘(A) the Secretary determines that the in-
formation submitted in the application (or the 
supplement) is sufficient to show that the bio-
logical product is biosimilar to the reference 
product; and’’; 
(4) by amending paragraph (4) to read as fol-
lows: 
‘‘(4) INTERCHANGEABILITY.— 
‘‘(A) IN GENERAL.—A biological product 
licensed under this subsection shall be deemed 
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to be interchangeable with the reference prod-
uct, subject to subparagraph (B). 
‘‘(B) TIMING OF DEEMED INTERCHANGE-
ABILITY.— 
‘‘(i) LICENSURE ON OR AFTER TRAN-
SITION
DATE.—A biological product li-
censed under this subsection on or after 
the transition date described in subpara-
graph (C) (referred to in this clause as the 
‘applicable biological product’) shall be 
deemed to be interchangeable with the ref-
erence product upon such licensure, unless 
the applicable biological product relied on 
the same reference product as another bio-
logical product for which— 
‘‘(I) licensure under this sub-
section was in effect on the day before 
the date of enactment of the Bio-
similar Red Tape Elimination Act; 
and 
‘‘(II) a first interchangeable ex-
clusivity period under paragraph (6) 
(as in effect on the day before the 
date of enactment of the Biosimilar 
Red Tape Elimination Act) is in effect 
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on the date of licensure of the applica-
ble biological product, 
in which case the applicable biological 
product shall be deemed interchangeable 
with the reference product under this para-
graph on the date on which the exclusivity 
period described in subclause (II) ends. 
‘‘(ii) LICENSURE
PRIOR
TO
TRANSI-
TION DATE.—A biological product licensed 
under this subsection prior to the transi-
tion date described in subparagraph (C) 
(referred to in this clause as the ‘applicable 
biological product’) shall be deemed to be 
interchangeable with the reference product 
on such transition date, unless the applica-
ble biological product relied on the same 
reference product as another biological 
product for which— 
‘‘(I) licensure under this sub-
section was in effect on the day before 
the date of enactment of the Bio-
similar Red Tape Elimination Act; 
and 
‘‘(II) a first interchangeable ex-
clusivity period under paragraph (6) 
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(as in effect on the day before the 
date of enactment of the Biosimilar 
Red Tape Elimination Act) is in effect 
on the transition date, 
in which case the applicable biological 
product shall be deemed interchangeable 
with the reference product under this para-
graph on the date on which the exclusivity 
period described in subclause (II) ends. 
‘‘(C) TRANSITION
DATE.—The transition 
date described in this subparagraph is the date 
that is 60 days after the date of enactment of 
the Biosimilar Red Tape Elimination Act.’’; 
(5) by amending paragraph (6) to read as fol-
lows: 
‘‘(6) TRANSITION
WITH
RESPECT
TO
PRE-
SERVING
FIRST
INTERCHANGEABLE
EXCLUSIVITY 
WITH
RESPECT
TO
CERTAIN
BIOLOGICAL
PROD-
UCTS.—With respect to a biological product licensed 
under this subsection before the date of enactment 
of the Biosimilar Red Tape Elimination Act, for 
which there was an unexpired period of first inter-
changeable exclusivity under this subsection (as then 
in effect), such unexpired exclusivity period shall re-
main in effect for the duration of such period.’’; and 
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(6) 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 Sec-
retary’’ and inserting ‘‘description of the cri-
teria that the Secretary’’. 
(b) CONFORMING AMENDMENTS.— 
(1) Section 351(i)(3) of the Public Health Serv-
ice 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 re-
questing that the Secretary determine that the bio-
similar biological product meets the standards for 
interchangeability described in section 351(k)(4) of 
the Public Health Service Act’’. 
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(4) Section 505B(l) of the Federal Food, Drug, 
and Cosmetic Act (21 U.S.C. 355c(l)) to read as fol-
lows: 
‘‘(l) BIOSIMILAR BIOLOGICAL PRODUCTS.—A biologi-
cal product for which an application is submitted under 
section 351(k) of the Public Health Service Act shall not 
be considered to have a new active ingredient for purposes 
of this section, unless the application seeks licensure for— 
‘‘(1) a claimed indication that has been ap-
proved for the reference product in a relevant pedi-
atric population or for which there is a deferral of 
the pediatric assessment under paragraph (4) for 
the reference product; and 
‘‘(2) the assessment would not involve the de-
velopment of a biological product with a strength, 
dosage form, route of administration, or condition of 
use that could not be licensed under section 351(k) 
of the Public Health Service Act.’’. 
(c) GUIDANCE.—The Secretary shall— 
(1) not later than 18 months after the date of 
enactment of this Act, update existing draft and 
final guidance to reflect the amendments made by 
this Act, including by revising or revoking the guid-
ance document titled ‘‘Considerations in Dem-
onstrating Interchangeability With a Reference 
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Product’’ (May 2019) and ‘‘Considerations in Dem-
onstrating Interchangeability With a Reference 
Product: Update’’ (June 2024); 
(2) not later than 18 months after the date of 
enactment of this Act, issue or revise guidance on 
review and approval of biosimilar biological products 
under section 351(k) of the Public Health Service 
Act (42 U.S.C. 262(k)) relating to the data and in-
formation that an applicant is required to submit to 
support a determination that a biosimilar biological 
product that is the subject of an application under 
such section is biosimilar to the reference product 
(as defined in section 351(i) of such Act (42 U.S.C. 
262(i))); and 
(3) not later than 18 months after the comment 
period closes on the guidance under paragraphs (1) 
and (2), issue revised draft or final versions of such 
guidances. 
(d) RULES OF CONSTRUCTION.—The amendments 
made by this section shall not be construed— 
(1) to alter the standard or the information re-
quired for licensure of a biological product as bio-
similar to a reference product pursuant to section 
351(k) of the Public Health Service Act (42 U.S.C. 
262(k)); or 
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(2) to limit the information that may be re-
quired by the Secretary of Health and Human Serv-
ices to support the licensure of a biological product 
as biosimilar to a reference product pursuant to 
such section. 
Æ 
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