I 
115TH CONGRESS 
2D SESSION 
H. R. 6478 
To enhance competition for prescription drugs by increasing the ability of 
the Department of Justice and Federal Trade Commission to enforce 
existing antitrust laws regarding biologic and biosimilar products, and 
for other purposes. 
IN THE HOUSE OF REPRESENTATIVES 
JULY 23, 2018 
Mr. SARBANES (for himself and Mr. JOHNSON of Ohio) introduced the 
following bill; which was referred to the Committee on Energy and Commerce 
A BILL 
To enhance competition for prescription drugs by increasing 
the ability of the Department of Justice and Federal 
Trade Commission to enforce existing antitrust laws re-
garding biologic and biosimilar products, and for other 
purposes. 
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 ‘‘Biosimilars Competi-
tion Act of 2018’’. 
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SEC. 2. LICENSURE PATHWAY FOR BIOSIMILAR BIOLOGI-
CAL PRODUCTS. 
Section 351(l) of the Public Health Service Act (42 
U.S.C. 262(l)) is amended by adding at the end the fol-
lowing: 
‘‘(10) NOTIFICATION OF AGREEMENTS.— 
‘‘(A) REQUIREMENTS.— 
‘‘(i) 
AGREEMENT
BETWEEN
BIO-
SIMILAR
PRODUCT
APPLICANT
AND
REF-
ERENCE
PRODUCT
SPONSOR.—If a sub-
section (k) applicant and the reference 
product sponsor enter into an agreement 
described in subparagraph (B), the appli-
cant and sponsor shall each file the agree-
ment in accordance with subparagraph 
(C). 
‘‘(ii) 
AGREEMENT
BETWEEN
BIO-
SIMILAR PRODUCT APPLICANTS.—If 2 or 
more subsection (k) applicants for bio-
similar products with the same reference 
product enter into an agreement described 
in subparagraph (B), the applicants shall 
each file the agreement in accordance with 
subparagraph (C). 
‘‘(B) SUBJECT MATTER OF AGREEMENT.— 
An agreement described in this subparagraph— 
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‘‘(i) is an agreement between a sub-
section (k) applicant and the reference 
product sponsor or between 2 or more sub-
section (k) applicants regarding the manu-
facture, marketing, or sale of— 
‘‘(I) the biosimilar product (or 
biosimilar products) for which an ap-
plication was submitted under sub-
section (k); or 
‘‘(II) the reference product; 
‘‘(ii) includes any agreement between 
a subsection (k) applicant and the ref-
erence product sponsor or between 2 or 
more subsection (k) applicants that is con-
tingent upon, provides a contingent condi-
tion for, or otherwise relates to an agree-
ment described in clause (i); and 
‘‘(iii) excludes any agreement that 
solely concerns— 
‘‘(I) purchase orders for raw ma-
terial supplies; 
‘‘(II) equipment and facility con-
tracts; 
‘‘(III) employment or consulting 
contracts; or 
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‘‘(IV) packaging and labeling 
contracts. 
‘‘(C) FILING.— 
‘‘(i) IN
GENERAL.—The text of an 
agreement required to be filed by subpara-
graph (A) shall be filed with the Assistant 
Attorney General in charge of the Anti-
trust Division of the Department of Jus-
tice (in this paragraph referred to as the 
‘Assistant Attorney General’) and the Fed-
eral Trade Commission not later than— 
‘‘(I) 10 business days after the 
date on which the agreement is exe-
cuted; and 
‘‘(II) prior to the date of the first 
commercial marketing of, for agree-
ments 
described 
in 
subparagraph 
(A)(i), the biosimilar product that is 
the subject of the application or, for 
agreements described in subparagraph 
(A)(ii), any biosimilar product that is 
the subject of an application described 
in such subparagraph. 
‘‘(ii) IF
AGREEMENT
NOT
REDUCED 
TO TEXT.—If an agreement required to be 
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filed by subparagraph (A) has not been re-
duced to text, the persons required to file 
the agreement shall each file written de-
scriptions of the agreement that are suffi-
cient to disclose all the terms and condi-
tions of the agreement. 
‘‘(iii) CERTIFICATION.—The chief ex-
ecutive officer or the company official re-
sponsible for negotiating any agreement re-
quired to be filed by subparagraph (A) 
shall include in any filing under this para-
graph a certification as follows: ‘I declare 
under penalty of perjury that the following 
is true and correct: The materials filed 
with the Federal Trade Commission and 
the Department of Justice under section 
351(l)(10) of the Public Health Service 
Act, with respect to the agreement ref-
erenced in this certification: (1) represent 
the complete, final, and exclusive agree-
ment between the parties; (2) include any 
ancillary agreements that are contingent 
upon, provide a contingent condition for, 
or are otherwise related to, the referenced 
agreement; and (3) include written descrip-
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tions of any oral agreements, representa-
tions, commitments, or promises between 
the parties that are responsive to such sec-
tion and have not been reduced to writ-
ing.’. 
‘‘(D) DISCLOSURE
EXEMPTION.—Any in-
formation or documentary material filed with 
the Assistant Attorney General or the Federal 
Trade Commission pursuant to this paragraph 
shall be exempt from disclosure under section 
552 of title 5, United States Code, and no such 
information or documentary material may be 
made public, except as may be relevant to any 
administrative or judicial action or proceeding. 
Nothing in this subparagraph prevents disclo-
sure of information or documentary material to 
either body of the Congress or to any duly au-
thorized committee or subcommittee of the Con-
gress. 
‘‘(E) ENFORCEMENT.— 
‘‘(i) CIVIL
PENALTY.—Any person 
that violates a provision of this paragraph 
shall be liable for a civil penalty of not 
more than the maximum amount of a civil 
penalty under section 1115(a) of the Medi-
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