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Federal Food, Drug, and Cosmetic Act with re-
spect to the licensure of a biological product 
under this subsection. Any such guidance may 
be general or specific. 
‘‘(B) PUBLIC COMMENT.— 
‘‘(i) IN
GENERAL.—The Secretary 
shall provide the public an opportunity to 
comment on any proposed guidance issued 
under subparagraph (A) before issuing 
final guidance. 
‘‘(ii) INPUT REGARDING MOST VALU-
ABLE GUIDANCE.—The Secretary shall es-
tablish a process through which the public 
may provide the Secretary with input re-
garding priorities for issuing guidance. 
‘‘(C) NO REQUIREMENT FOR APPLICATION 
CONSIDERATION.—The 
issuance 
(or 
non- 
issuance) of guidance under subparagraph (A) 
shall not preclude the review of, or action on, 
an application submitted under this subsection. 
‘‘(D) REQUIREMENT FOR PRODUCT CLASS- 
SPECIFIC
GUIDANCE.—If the Secretary issues 
product class-specific guidance under subpara-
graph (A), such guidance shall include a de-
scription of— 
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‘‘(i) the criteria that the Secretary will 
use to determine whether a biological prod-
uct is highly similar to a reference product 
in such product class; and 
‘‘(ii) the criteria, if available, that the 
Secretary will use to determine whether a 
biological product meets the standards de-
scribed in paragraph (4). 
‘‘(E) CERTAIN PRODUCT CLASSES.— 
‘‘(i) GUIDANCE.—The Secretary may 
indicate in a guidance document that the 
science and experience, as of the date of 
such guidance, with respect to a product or 
product class (not including any recom-
binant protein) does not allow approval of 
an application for a license as provided 
under this subsection for such product or 
product class. 
‘‘(ii) MODIFICATION OR REVERSAL.— 
The Secretary may issue a subsequent 
guidance document under subparagraph 
(A) to modify or reverse a guidance docu-
ment under clause (i). 
‘‘(iii) NO
EFFECT
ON
ABILITY
TO 
DENY
LICENSE.—Clause (i) shall not be 
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construed to require the Secretary to ap-
prove a product with respect to which the 
Secretary has not indicated in a guidance 
document that the science and experience, 
as described in clause (i), does not allow 
approval of such an application. 
‘‘(10) NAMING.—The Secretary shall ensure 
that the labeling and packaging of each biological 
product licensed under this subsection bears a name 
that uniquely identifies the biological product and 
distinguishes it from the reference product and any 
other biological products licensed under this sub-
section following evaluation against such reference 
product. 
‘‘(l) PATENT NOTICES; RELATIONSHIP TO FINAL AP-
PROVAL.— 
‘‘(1) DEFINITIONS.—For the purposes of this 
subsection, the term— 
‘‘(A) ‘biosimilar product’ means the bio-
logical product that is the subject of the appli-
cation under subsection (k); 
‘‘(B) ‘relevant patent’ means a patent 
that— 
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‘‘(i) expires after the date specified in 
subsection (k)(7)(A) that applies to the 
reference product; and 
‘‘(ii) could reasonably be asserted 
against the applicant due to the unauthor-
ized making, use, sale, or offer for sale 
within the United States, or the importa-
tion into the United States of the bio-
similar product, or materials used in the 
manufacture of the biosimilar product, or 
due to a use of the biosimilar product in 
a method of treatment that is indicated in 
the application; 
‘‘(C) ‘reference product sponsor’ means the 
holder of an approved application or license for 
the reference product; and 
‘‘(D) ‘interested third party’ means a per-
son other than the reference product sponsor 
that owns a relevant patent, or has the right to 
commence or participate in an action for in-
fringement of a relevant patent. 
‘‘(2) HANDLING OF CONFIDENTIAL INFORMA-
TION.—Any entity receiving confidential information 
pursuant to this subsection shall designate one or 
more individuals to receive such information. Each 
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individual so designated shall execute an agreement 
in accordance with regulations promulgated by the 
Secretary. The regulations shall require each such 
individual to take reasonable steps to maintain the 
confidentiality of information received pursuant to 
this subsection and use the information solely for 
purposes authorized by this subsection. The obliga-
tions imposed on an individual who has received con-
fidential information pursuant to this subsection 
shall continue until the individual returns or de-
stroys the confidential information, a court imposes 
a protective order that governs the use or handling 
of the confidential information, or the party pro-
viding the confidential information agrees to other 
terms or conditions regarding the handling or use of 
the confidential information. 
‘‘(3) PUBLIC NOTICE BY SECRETARY.—Within 
30 days of acceptance by the Secretary of an appli-
cation filed under subsection (k), the Secretary shall 
publish a notice identifying— 
‘‘(A) the reference product identified in the 
application; and 
‘‘(B) the name and address of an agent 
designated by the applicant to receive notices 
pursuant to paragraph (4)(B). 
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‘‘(4) EXCHANGES CONCERNING PATENTS.— 
‘‘(A) 
EXCHANGES
WITH
REFERENCE 
PRODUCT SPONSOR.— 
‘‘(i) Within 30 days of the date of ac-
ceptance of the application by the Sec-
retary, the applicant shall provide the ref-
erence product sponsor with a copy of the 
application and information concerning the 
biosimilar product and its production. This 
information shall include a detailed de-
scription of the biosimilar product, its 
method of manufacture, and the materials 
used in the manufacture of the product. 
‘‘(ii) Within 60 days of the date of re-
ceipt of the information required to be pro-
vided under clause (i), the reference prod-
uct sponsor shall provide to the applicant 
a list of relevant patents owned by the ref-
erence product sponsor, or in respect of 
which the reference product sponsor has 
the right to commence an action of in-
fringement or otherwise has an interest in 
the patent as such patent concerns the bio-
similar product. 
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written statement regarding each identified pat-
ent to the party that identified the patent. Such 
statement shall either— 
‘‘(i) state that the applicant will not 
commence marketing of the biosimilar 
product and has requested the Secretary to 
not grant final approval of the application 
before the date of expiration of the noticed 
patent; or 
‘‘(ii) provide a detailed written expla-
nation setting forth the reasons why the 
applicant believes— 
‘‘(I) the making, use, sale, or 
offer for sale within the United 
States, or the importation into the 
United States, of the biosimilar prod-
uct, or the use of the biosimilar prod-
uct in a treatment indicated in the ap-
plication, would not infringe the pat-
ent; or 
‘‘(II) the patent is invalid or un-
enforceable. 
‘‘(5) ACTION
FOR
INFRINGEMENT
INVOLVING 
REFERENCE PRODUCT SPONSOR.—If an action for 
infringement concerning a relevant patent identified 
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by the reference product sponsor under clause (ii) or 
(iii) of paragraph (4)(A), or by an interested third 
party under clause (iii) or (iv) of paragraph (4)(B), 
is brought within 60 days of the date of receipt of 
a statement under paragraph (4)(D)(ii), and the 
court in which such action has been commenced de-
termines the patent is infringed prior to the date ap-
plicable under subsection (k)(7)(A) or (k)(8), the 
Secretary shall make approval of the application ef-
fective on the day after the date of expiration of the 
patent that has been found to be infringed. If more 
than one such patent is found to be infringed by the 
court, the approval of the application shall be made 
effective on the day after the date that the last such 
patent expires. 
‘‘(6) NOTIFICATION OF AGREEMENTS.— 
‘‘(A) REQUIREMENTS.— 
‘‘(i) 
AGREEMENT
BETWEEN
BIO-
SIMILAR
PRODUCT
APPLICANT
AND
REF-
ERENCE
PRODUCT
SPONSOR.—If a bio-
similar product applicant under subsection 
(k) and the reference product sponsor 
enter into an agreement described in sub-
paragraph (B), the applicant and sponsor 
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shall each file the agreement in accordance 
with subparagraph (C). 
‘‘(ii) 
AGREEMENT
BETWEEN
BIO-
SIMILAR PRODUCT APPLICANTS.—If 2 or 
more biosimilar product applicants submit 
an application under subsection (k) for bio-
similar products with the same reference 
product and enter into an agreement de-
scribed in subparagraph (B), the appli-
cants shall each file the agreement in ac-
cordance with subparagraph (C). 
‘‘(B) SUBJECT MATTER OF AGREEMENT.— 
An agreement described in this subparagraph— 
‘‘(i) is an agreement between the bio-
similar product applicant under subsection 
(k) and the reference product sponsor or 
between 2 or more biosimilar product ap-
plicants under subsection (k) regarding the 
manufacture, marketing, or sale of— 
‘‘(I) the biosimilar product (or 
biosimilar products) for which an ap-
plication was submitted; or 
‘‘(II) the reference product; 
‘‘(ii) includes any agreement between 
the biosimilar product applicant under sub-
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section (k) and the reference product spon-
sor or between 2 or more biosimilar prod-
uct applicants under subsection (k) that is 
contingent upon, provides a contingent 
condition for, or otherwise relates to an 
agreement 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 
‘‘(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 and the Federal Trade 
Commission not later than— 
‘‘(I) 10 business days after the 
date on which the agreement is exe-
cuted; and 
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‘‘(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 
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 
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with the Federal Trade Commission and 
the Department of Justice under section 
351(l)(6) of the Public Health Service Act, 
with respect to the agreement referenced in 
this certification: (1) represent the com-
plete, final, and exclusive agreement be-
tween the parties; (2) include any ancillary 
agreements that are contingent upon, pro-
vide a contingent condition for, or are oth-
erwise related to, the referenced agree-
ment; and (3) include written descriptions 
of any oral agreements, representations, 
commitments, or promises between the 
parties that are responsive to such section 
and have not been reduced to writing.’. 
‘‘(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-
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