182 
uncollected debt related to the Medicare or 
Medicaid programs; 
(B) may deny approval if the Secretary de-
termines that these affiliations pose undue risk 
to the Medicare or Medicaid program, subject 
to an appeals process for the applicant as deter-
mined by the Secretary; and 
(C) may implement enhanced safeguards 
(such as surety bonds). 
(b) MORATORIA.—The Secretary may impose mora-
toria on approval of provider and supplier numbers under 
the Medicare program for new providers of services and 
suppliers as determined necessary to prevent or combat 
fraud a period of delay for any one applicant cannot ex-
ceed 30 days unless cause is shown by the Secretary. 
(c) FUNDING.— 
(1) IN GENERAL.—There are authorized to be 
appropriated to carry out this section such sums as 
may be necessary. 
(2) CONDITION.—The provisions of paragraphs 
(1) and (2) of subsection (a) shall not apply unless 
and until funds are appropriated to carry out such 
provisions. 
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SEC. 605. TRACKING BANNED PROVIDERS ACROSS STATE 
LINES. 
(a) GREATER COORDINATION.—The Secretary of 
Health and Human Services shall provide for increased 
coordination between the Administrator of the Centers for 
Medicare & Medicaid Services (in this section referred to 
as ‘‘CMS’’) and its regional offices to ensure that pro-
viders of services and suppliers that have operated in one 
State and are excluded from participation in the Medicare 
program are unable to begin operation and participation 
in the Medicare program in another State. 
(b) IMPROVED INFORMATION SYSTEMS.— 
(1) IN GENERAL.—The Secretary shall improve 
information systems to allow greater integration be-
tween databases under the Medicare program so 
that— 
(A) Medicare administrative contractors, 
fiscal intermediaries, and carriers have imme-
diate access to information identifying providers 
and suppliers excluded from participation in the 
Medicare and Medicaid program and other Fed-
eral health care programs; and 
(B) such information can be shared across 
Federal health care programs and agencies, in-
cluding between the Departments of Health and 
Human Services, the Social Security Adminis-
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tration, the Department of Veterans Affairs, 
the Department of Defense, the Department of 
Justice, and the Office of Personnel Manage-
ment. 
(c) MEDICARE/MEDICAID ‘‘ONE PI’’ DATABASE.— 
The Secretary shall implement a database that includes 
claims and payment data for all components of the Medi-
care program and the Medicaid program. 
(d) AUTHORIZING EXPANDED DATA MATCHING.— 
Notwithstanding any provision of the Computer Matching 
and Privacy Protection Act of 1988 to the contrary— 
(1) the Secretary and the Inspector General in 
the Department of Health and Human Services may 
perform data matching of data from the Medicare 
program with data from the Medicaid program; and 
(2) the Commissioner of Social Security and the 
Secretary may perform data matching of data of the 
Social Security Administration with data from the 
Medicare and Medicaid programs. 
(e) CONSOLIDATION OF DATABASES.—The Secretary 
shall consolidate and expand into a centralized database 
for individuals and entities that have been excluded from 
Federal health care programs the Healthcare Integrity 
and Protection Data Bank, the National Practitioner 
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Data Bank, the List of Excluded Individuals/Entities, and 
a national patient abuse/neglect registry. 
(f) COMPREHENSIVE PROVIDER DATABASE.— 
(1) ESTABLISHMENT.—The Secretary shall es-
tablish a comprehensive database that includes infor-
mation on providers of services, suppliers, and re-
lated entities participating in the Medicare program, 
the Medicaid program, or both. Such database shall 
include, information on ownership and business rela-
tionships, history of adverse actions, results of site 
visits or other monitoring by any program. 
(2) USE.—Prior to issuing a provider or sup-
plier number for an entity under the Medicare pro-
gram, the Secretary shall obtain information on the 
entity from such database to assure the entity quali-
fies for the issuance of such a number. 
(g) COMPREHENSIVE SANCTIONS DATABASE.—The 
Secretary shall establish a comprehensive sanctions data-
base on sanctions imposed on providers of services, sup-
pliers, and related entities. Such database shall be over-
seen by the Inspector General of the Department of 
Health and Human Services and shall be linked to related 
databases maintained by State licensure boards and by 
Federal or State law enforcement agencies. 
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(h) ACCESS
TO
CLAIMS
AND
PAYMENT
DATA-
BASES.—The Secretary shall ensure that the Inspector 
General of the Department of Health and Human Services 
and Federal law enforcement agencies have direct access 
to all claims and payment databases of the Secretary 
under the Medicare or Medicaid programs. 
(i) CIVIL MONEY PENALTIES FOR SUBMISSION OF 
ERRONEOUS INFORMATION.—In the case of a provider of 
services, supplier, or other entity that submits erroneous 
information that serves as a basis for payment of any enti-
ty under the Medicare or Medicaid program, the Secretary 
may impose a civil money penalty of not to exceed $50,000 
for each such erroneous submission. A civil money penalty 
under this subsection shall be imposed and collected in the 
same manner as a civil money penalty under subsection 
(a) of section 1128A of the Social Security Act is imposed 
and collected under that section. 
DIVISION G—PATHWAY FOR BIO-
SIMILAR BIOLOGICAL PROD-
UCTS 
SEC. 701. LICENSURE PATHWAY FOR BIOSIMILAR BIOLOGI-
CAL PRODUCTS. 
(a) LICENSURE OF BIOLOGICAL PRODUCTS AS BIO-
SIMILAR
OR INTERCHANGEABLE.—Section 351 of the 
Public Health Service Act (42 U.S.C. 262) is amended— 
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‘‘(bb) animal studies (includ-
ing the assessment of toxicity); 
and 
‘‘(cc) a clinical study or 
studies (including the assessment 
of immunogenicity and phar-
macokinetics 
or 
pharmacodynamics) that are suf-
ficient to demonstrate safety, pu-
rity, and potency in 1 or more 
appropriate conditions of use for 
which the reference product is li-
censed and intended to be used 
and for which licensure is sought 
for the biological product; 
‘‘(II) the biological product and 
reference product utilize the same 
mechanism or mechanisms of action 
for the condition or conditions of use 
prescribed, recommended, or sug-
gested in the proposed labeling, but 
only to the extent the mechanism or 
mechanisms of action are known for 
the reference product; 
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‘‘(III) the condition or conditions 
of use prescribed, recommended, or 
suggested in the labeling proposed for 
the biological product have been pre-
viously approved for the reference 
product; 
‘‘(IV) the route of administra-
tion, the dosage form, and the 
strength of the biological product are 
the same as those of the reference 
product; and 
‘‘(V) the facility in which the bio-
logical product is manufactured, proc-
essed, packed, or held meets stand-
ards designed to assure that the bio-
logical product continues to be safe, 
pure, and potent. 
‘‘(ii) 
DETERMINATION
BY
SEC-
RETARY.—The Secretary may determine, 
in the Secretary’s discretion, that an ele-
ment described in clause (i)(I) is unneces-
sary in an application submitted under this 
subsection. 
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‘‘(iii) ADDITIONAL
INFORMATION.— 
An application submitted under this sub-
section— 
‘‘(I) shall include publicly avail-
able information regarding the Sec-
retary’s previous determination that 
the reference product is safe, pure, 
and potent; and 
‘‘(II) may include any additional 
information in support of the applica-
tion, including publicly available infor-
mation with respect to the reference 
product or another biological product. 
‘‘(B) INTERCHANGEABILITY.—An applica-
tion (or a supplement to an application) sub-
mitted under this subsection may include infor-
mation demonstrating that the biological prod-
uct meets the standards described in paragraph 
(4). 
‘‘(3) EVALUATION BY SECRETARY.—Upon re-
view of an application (or a supplement to an appli-
cation) submitted under this subsection, the Sec-
retary shall license the biological product under this 
subsection if— 
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‘‘(A) the Secretary determines that the in-
formation submitted in the application (or the 
supplement) is sufficient to show that the bio-
logical product— 
‘‘(i) is biosimilar to the reference 
product; or 
‘‘(ii) meets the standards described in 
paragraph (4), and therefore is inter-
changeable with the reference product; and 
‘‘(B) the applicant (or other appropriate 
person) consents to the inspection of the facility 
that is the subject of the application, in accord-
ance with subsection (c). 
‘‘(4) SAFETY
STANDARDS
FOR
DETERMINING 
INTERCHANGEABILITY.—Upon review of an applica-
tion submitted under this subsection or any supple-
ment to such application, the Secretary shall deter-
mine the biological product to be interchangeable 
with the reference product if the Secretary deter-
mines that the information submitted in the applica-
tion (or a supplement to such application) is suffi-
cient to show that— 
‘‘(A) the biological product— 
‘‘(i) is biosimilar to the reference 
product; and 
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‘‘(ii) can be expected to produce the 
same clinical result as the reference prod-
uct in any given patient; and 
‘‘(B) for a biological product that is ad-
ministered more than once to an individual, the 
risk in terms of safety or diminished efficacy of 
alternating or switching between use of the bio-
logical product and the reference product is not 
greater than the risk of using the reference 
product without such alternation or switch. 
‘‘(5) GENERAL RULES.— 
‘‘(A) ONE REFERENCE PRODUCT PER AP-
PLICATION.—A biological product, in an appli-
cation submitted under this subsection, may not 
be evaluated against more than 1 reference 
product. 
‘‘(B) REVIEW.—An application submitted 
under this subsection shall be reviewed by the 
division within the Food and Drug Administra-
tion that is responsible for the review and ap-
proval of the application under which the ref-
erence product is licensed. 
‘‘(C) RISK EVALUATION AND MITIGATION 
STRATEGIES.—The authority of the Secretary 
with respect to risk evaluation and mitigation 
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strategies under the Federal Food, Drug, and 
Cosmetic Act shall apply to biological products 
licensed under this subsection in the same man-
ner as such authority applies to biological prod-
ucts licensed under subsection (a). 
‘‘(D) RESTRICTIONS ON BIOLOGICAL PROD-
UCTS
CONTAINING
DANGEROUS
INGREDI-
ENTS.—If information in an application sub-
mitted under this subsection, in a supplement 
to such an application, or otherwise available to 
the Secretary shows that a biological product— 
‘‘(i) is, bears, or contains a select 
agent or toxin listed in section 73.3 or 
73.4 of title 42, section 121.3 or 121.4 of 
title 9, or section 331.3 of title 7, Code of 
Federal Regulations (or any successor reg-
ulations); or 
‘‘(ii) is, bears, or contains a controlled 
substance in schedule I or II of section 
202 of the Controlled Substances Act, as 
listed in part 1308 of title 21, Code of 
Federal Regulations (or any successor reg-
ulations); 
the Secretary shall not license the biological 
product under this subsection unless the Sec-
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retary determines, after consultation with ap-
propriate national security and drug enforce-
ment agencies, that there would be no increased 
risk to the security or health of the public from 
licensing such biological product under this sub-
section. 
‘‘(6) EXCLUSIVITY FOR FIRST INTERCHANGE-
ABLE
BIOLOGICAL
PRODUCT.—Upon review of an 
application submitted under this subsection relying 
on the same reference product for which a prior bio-
logical product has received a determination of inter-
changeability for any condition of use, the Secretary 
shall not make a determination under paragraph (4) 
that the second or subsequent biological product is 
interchangeable for any condition of use until the 
earlier of— 
‘‘(A) 1 year after the first commercial 
marketing of the first interchangeable bio-
similar biological product to be approved as 
interchangeable for that reference product; 
‘‘(B) 18 months after— 
‘‘(i) a final court decision on all pat-
ents in suit in an action instituted under 
subsection (l)(5) against the applicant that 
submitted the application for the first ap-
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proved interchangeable biosimilar biological 
product; or 
‘‘(ii) the dismissal with or without 
prejudice of an action instituted under sub-
section (l)(5) against the applicant that 
submitted the application for the first ap-
proved interchangeable biosimilar biological 
product; or 
‘‘(C)(i) 42 months after approval of the 
first interchangeable biosimilar biological prod-
uct if the applicant that submitted such appli-
cation has been sued under subsection (l)(5) 
and such litigation is still ongoing within such 
42-month period; or 
‘‘(ii) 18 months after approval of the first 
interchangeable biosimilar biological product if 
the applicant that submitted such application 
has not been sued under subsection (l)(5). 
For purposes of this paragraph, the term ‘final court 
decision’ means a final decision of a court from 
which no appeal (other than a petition to the United 
States Supreme Court for a writ of certiorari) has 
been or can be taken. 
‘‘(7) EXCLUSIVITY
FOR
REFERENCE
PROD-
UCT.— 
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‘‘(A) EFFECTIVE DATE OF BIOSIMILAR AP-
PLICATION APPROVAL.—Approval of an applica-
tion under this subsection may not be made ef-
fective by the Secretary until the date that is 
12 years after the date on which the reference 
product was first licensed under subsection (a). 
‘‘(B) FILING
PERIOD.—An application 
under this subsection may not be submitted to 
the Secretary until the date that is 4 years 
after the date on which the reference product 
was first licensed under subsection (a). 
‘‘(C) FIRST
LICENSURE.—Subparagraphs 
(A) and (B) shall not apply to a license for or 
approval of— 
‘‘(i) a supplement for the biological 
product that is the reference product; or 
‘‘(ii) a subsequent application filed by 
the same sponsor or manufacturer of the 
biological product that is the reference 
product (or a licensor, predecessor in inter-
est, or other related entity) for— 
‘‘(I) a change (not including a 
modification to the structure of the bi-
ological product) that results in a new 
indication, route of administration, 
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dosing schedule, dosage form, delivery 
system, delivery device, or strength; or 
‘‘(II) a modification to the struc-
ture of the biological product that 
does not result in a change in safety, 
purity, or potency. 
‘‘(8) PEDIATRIC STUDIES.— 
‘‘(A) EXCLUSIVITY.—If, before or after li-
censure of the reference product under sub-
section (a) of this section, the Secretary deter-
mines that information relating to the use of 
such product in the pediatric population may 
produce health benefits in that population, the 
Secretary makes a written request for pediatric 
studies (which shall include a timeframe for 
completing such studies), the applicant or hold-
er of the approved application agrees to the re-
quest, such studies are completed using appro-
priate formulations for each age group for 
which the study is requested within any such 
timeframe, and the reports thereof are sub-
mitted and accepted in accordance with section 
505A(d)(3) of the Federal Food, Drug, and 
Cosmetic Act the period referred to in para-
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graph (7)(A) of this subsection is deemed to be 
12 years and 6 months rather than 12 years. 
‘‘(B) EXCEPTION.—The Secretary shall 
not extend the period referred to in subpara-
graph (A) of this paragraph if the determina-
tion under section 505A(d)(3) of the Federal 
Food, Drug, and Cosmetic Act is made later 
than 9 months prior to the expiration of such 
period. 
‘‘(C) APPLICATION
OF
CERTAIN
PROVI-
SIONS.—The provisions of subsections (a), (d), 
(e), (f), (h), (j), (k), and (l) of section 505A of 
the Federal Food, Drug, and Cosmetic Act 
shall apply with respect to the extension of a 
period under subparagraph (A) of this para-
graph to the same extent and in the same man-
ner as such provisions apply with respect to the 
extension of a period under subsection (b) or 
(c) of section 505A of the Federal Food, Drug, 
and Cosmetic Act. 
‘‘(9) GUIDANCE DOCUMENTS.— 
‘‘(A) IN
GENERAL.—The Secretary may, 
after opportunity for public comment, issue 
guidance in accordance, except as provided in 
subparagraph (B)(i), with section 701(h) of the 
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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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‘‘(iii) If the reference product sponsor 
is issued or acquires an interest in a rel-
evant patent after the date on which the 
reference product sponsor provides the list 
required by clause (ii) to the applicant, the 
reference product sponsor shall identify 
that patent to the applicant within 30 days 
of the date of issue of the patent, or the 
date of acquisition of the interest in the 
patent, as applicable. 
‘‘(B) 
EXCHANGES
WITH
INTERESTED 
THIRD PARTIES.— 
‘‘(i) At any time after the date on 
which the Secretary publishes a notice for 
an application under paragraph (3), any 
interested third party may provide notice 
to the designated agent of the applicant 
that the interested third party owns or has 
rights under 1 or more patents that may 
be relevant patents. The notice shall iden-
tify at least 1 patent and shall designate 
an individual who has executed an agree-
ment in accordance with paragraph (2) to 
receive confidential information from the 
applicant. 
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206 
‘‘(ii) Within 30 days of the date of re-
ceiving notice pursuant to clause (i), the 
applicant shall send to the individual des-
ignated by the interested third party the 
information 
specified 
in 
subparagraph 
(A)(i), unless the applicant and interested 
third party otherwise agree. 
‘‘(iii) Within 90 days of the date of 
receiving information pursuant to clause 
(ii), the interested third party shall provide 
to the applicant a list of relevant patents 
which the interested third party owns, or 
in respect of which the interested third 
party has the right to commence or partici-
pate in an action for infringement. 
‘‘(iv) If the interested third party is 
issued or acquires an interest in a relevant 
patent after the date on which the inter-
ested third party provides the list required 
by clause (iii), the interested third party 
shall identify that patent within 30 days of 
the date of issue of the patent, or the date 
of acquisition of the interest in the patent, 
as applicable. 
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207 
‘‘(C) IDENTIFICATION OF BASIS FOR IN-
FRINGEMENT.—For any patent identified under 
clause (ii) or (iii) of subparagraph (A) or under 
clause (iii) or (iv) of subparagraph (B), the ref-
erence product sponsor or the interested third 
party, as applicable— 
‘‘(i) shall explain in writing why the 
sponsor or the interested third party be-
lieves the relevant patent would be in-
fringed by the making, use, sale, or offer 
for sale within the United States, or im-
portation into the United States, of the 
biosimilar product or by a use of the bio-
similar product in treatment that is indi-
cated in the application; 
‘‘(ii) may specify whether the relevant 
patent is available for licensing; and 
‘‘(iii) shall specify the number and 
date of expiration of the relevant patent. 
‘‘(D) CERTIFICATION BY APPLICANT CON-
CERNING
IDENTIFIED
RELEVANT
PATENTS.— 
Not later than 45 days after the date on which 
a patent is identified under clause (ii) or (iii) of 
subparagraph (A) or under clause (iii) or (iv) of 
subparagraph (B), the applicant shall send a 
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208 
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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209 
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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210 
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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211 
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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212 
‘‘(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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214 
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 $11,000 for each day on which 
the violation occurs. Such penalty may be 
recovered in a civil action— 
‘‘(I) brought by the United 
States; or 
‘‘(II) brought by the Federal 
Trade Commission in accordance with 
the procedures established in section 
16(a)(1) of the Federal Trade Com-
mission Act. 
‘‘(ii) COMPLIANCE
AND
EQUITABLE 
RELIEF.—If any person violates any provi-
sion of this paragraph, the United States 
district court may order compliance, and 
may grant such other equitable relief as 
the court in its discretion determines nec-
essary or appropriate, upon application of 
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215 
the Assistant Attorney General or the Fed-
eral Trade Commission. 
‘‘(F) RULEMAKING.—The Federal Trade 
Commission, with the concurrence of the Assist-
ant Attorney General and by rule in accordance 
with section 553 of title 5, United States Code, 
consistent with the purposes of this para-
graph— 
‘‘(i) may define the terms used in this 
paragraph; 
‘‘(ii) may exempt classes of persons or 
agreements from the requirements of this 
paragraph; and 
‘‘(iii) may prescribe such other rules 
as may be necessary and appropriate to 
carry out the purposes of this paragraph. 
‘‘(G) SAVINGS CLAUSE.—Any action taken 
by the Assistant Attorney General or the Fed-
eral Trade Commission, or any failure of the 
Assistant Attorney General or the Commission 
to take action, under this paragraph shall not 
at any time bar any proceeding or any action 
with respect to any agreement between a bio-
similar product applicant under subsection (k) 
and the reference product sponsor, or any 
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216 
agreement between biosimilar product appli-
cants under subsection (k), under any other 
provision of law, nor shall any filing under this 
paragraph constitute or create a presumption of 
any violation of any competition laws.’’. 
(b) DEFINITIONS.—Section 351(i) of the Public 
Health Service Act (42 U.S.C. 262(i)) is amended— 
(1) by striking ‘‘In this section, the term ‘bio-
logical product’ means’’ and inserting the following: 
‘‘In this section: 
‘‘(1) The term ‘biological product’ means’’; 
(2) in paragraph (1), as so designated, by in-
serting ‘‘protein (except any chemically synthesized 
polypeptide),’’ after ‘‘allergenic product,’’; and 
(3) by adding at the end the following: 
‘‘(2) The term ‘biosimilar’ or ‘biosimilarity’, in 
reference to a biological product that is the subject 
of an application under subsection (k), means— 
‘‘(A) that the biological product is highly 
similar to the reference product notwith-
standing minor differences in clinically inactive 
components; and 
‘‘(B) there are no clinically meaningful dif-
ferences between the biological product and the 
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217 
reference product in terms of the safety, purity, 
and potency of the product. 
‘‘(3) The term ‘interchangeable’ or ‘inter-
changeability’, in reference to a biological product 
that is shown to meet the standards described in 
subsection (k)(4), means that the biological product 
may be substituted for the reference product without 
the intervention of the health care provider who pre-
scribed the reference product. 
‘‘(4) The term ‘reference product’ means the 
single biological product licensed under subsection 
(a) against which a biological product is evaluated in 
an application submitted under subsection (k).’’. 
(c) PRODUCTS PREVIOUSLY APPROVED UNDER SEC-
TION 505.— 
(1) REQUIREMENT TO FOLLOW SECTION 351.— 
Except as provided in paragraph (2), an application 
for a biological product shall be submitted under 
section 351 of the Public Health Service Act (42 
U.S.C. 262) (as amended by this Act). 
(2) EXCEPTION.—An application for a biologi-
cal product may be submitted under section 505 of 
the Federal Food, Drug, and Cosmetic Act (21 
U.S.C. 355) if— 
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218 
(A) such biological product is in a product 
class for which a biological product in such 
product class is the subject of an application 
approved under such section 505 not later than 
the date of enactment of this Act; and 
(B) such application— 
(i) has been submitted to the Sec-
retary of Health and Human Services (re-
ferred to in this Act as the ‘‘Secretary’’) 
before the date of enactment of this Act; 
or 
(ii) is submitted to the Secretary not 
later than the date that is 10 years after 
the date of enactment of this Act. 
(3) LIMITATION.—Notwithstanding paragraph 
(2), an application for a biological product may not 
be submitted under section 505 of the Federal Food, 
Drug, and Cosmetic Act (21 U.S.C. 355) if there is 
another biological product approved under sub-
section (a) of section 351 of the Public Health Serv-
ice Act that could be a reference product with re-
spect to such application (within the meaning of 
such section 351) if such application were submitted 
under subsection (k) of such section 351. 
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219 
(4) DEEMED APPROVED UNDER SECTION 351.— 
An approved application for a biological product 
under section 505 of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 355) shall be deemed to be 
a license for the biological product under such sec-
tion 351 on the date that is 10 years after the date 
of enactment of this Act. 
(5) DEFINITIONS.—For purposes of this sub-
section, the term ‘‘biological product’’ has the mean-
ing given such term under section 351 of the Public 
Health Service Act (42 U.S.C. 262) (as amended by 
this Act). 
SEC. 702. FEES RELATING TO BIOSIMILAR BIOLOGICAL 
PRODUCTS. 
Subparagraph (B) of section 735(1) of the Federal 
Food, Drug, and Cosmetic Act (21 U.S.C. 379g(1)) is 
amended by inserting ‘‘, including licensure of a biological 
product under section 351(k) of such Act’’ before the pe-
riod at the end. 
SEC. 703. AMENDMENTS TO CERTAIN PATENT PROVISIONS. 
(a) Section 271(e)(2) of title 35, United States Code 
is amended— 
(1) in subparagraph (A), by striking ‘‘or’’ after 
‘‘patent,’’; 
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220 
(2) in subparagraph (B), by adding ‘‘or’’ after 
the comma at the end; 
(3) by inserting the following after subpara-
graph (B): 
‘‘(C) 
a 
statement 
under 
section 
351(l)(4)(D)(ii) of the Public Health Service 
Act,’’; and 
(4) in the matter following subparagraph (C) 
(as added by paragraph (3)), by inserting before the 
period the following: ‘‘, or if the statement described 
in subparagraph (C) is provided in connection with 
an application to obtain a license to engage in the 
commercial manufacture, use, or sale of a biological 
product claimed in a patent or the use of which is 
claimed in a patent before the expiration of such 
patent’’. 
(b) Section 271(e)(4) of title 35, United States Code, 
is amended by striking ‘‘in paragraph (2)’’ in both places 
it appears and inserting ‘‘in paragraph (2)(A) or (2)(B)’’. 
Æ 
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