I 
111TH CONGRESS 
1ST SESSION H. R. 1548 
To amend the Public Health Service Act to establish a pathway for the 
licensure of biosimilar biological products, and for other purposes. 
IN THE HOUSE OF REPRESENTATIVES 
MARCH 17, 2009 
Ms. ESHOO (for herself, Mr. INSLEE, Mr. BARTON of Texas, Mr. GENE 
GREEN of Texas, Ms. BALDWIN, Mr. ROGERS of Michigan, Mrs. BONO 
MACK, Mr. HILL, Mr. UPTON, Mr. BARROW, Mr. PITTS, Mr. THOMPSON 
of California, Mr. CAPUANO, Mrs. DAVIS of California, Mr. BILBRAY, Mr. 
DREIER, Mr. ELLSWORTH, Mr. MCGOVERN, Mr. HERGER, Mr. DENT, 
Mr. GERLACH, Mr. BISHOP of New York, Ms. ZOE LOFGREN of Cali-
fornia, Mr. PENCE, Mr. SOUDER, Mr. HONDA, Mrs. TAUSCHER, Mr. 
SCALISE, Mr. TOWNS, Mr. CROWLEY, Mr. ISSA, Mr. PATRICK J. MURPHY 
of Pennsylvania, Ms. BEAN, Mr. DELAHUNT, Mr. SMITH of Washington, 
Mr. MCCARTHY of California, Mr. NEAL of Massachusetts, Mr. LYNCH, 
Mr. DONNELLY of Indiana, Mr. HALL of Texas, Mr. LANCE, Mr. HOLT, 
Mr. NUNES, and Mr. KIND) introduced the following bill; which was re-
ferred to the Committee on Energy and Commerce, and in addition to 
the Committee on the Judiciary, for a period to be subsequently deter-
mined by the Speaker, in each case for consideration of such provisions 
as fall within the jurisdiction of the committee concerned 
A BILL 
To amend the Public Health Service Act to establish a path-
way for the licensure of biosimilar biological 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, 
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SECTION 1. SHORT TITLE. 
This Act may be cited as the ‘‘Pathway for 
Biosimilars Act’’. 
SEC. 2. TABLE OF CONTENTS. 
The table of contents for this Act is as follows: 
Sec. 1. Short title. 
Sec. 2. Table of contents. 
TITLE I—AMENDMENTS TO PUBLIC HEALTH SERVICE ACT 
Sec. 101. Approval pathway for biosimilar biological products. 
Sec. 102. Fees relating to biosimilar biological products. 
TITLE II—AMENDMENTS TO PATENT ACT 
Sec. 201. Amendments to certain patent provisions. 
TITLE I—AMENDMENTS TO 
PUBLIC HEALTH SERVICE ACT 
SEC. 101. 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— 
(1) in subsection (a)(1)(A), by inserting ‘‘under 
this subsection or subsection (k)’’ after ‘‘biologics li-
cense’’; and 
(2) by adding at the end the following: 
‘‘(k) LICENSURE OF BIOLOGICAL PRODUCTS AS BIO-
SIMILAR.— 
‘‘(1) IN GENERAL.—Any person may submit an 
application for licensure of a biological product 
under this subsection. 
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‘‘(2) CONTENT.— 
‘‘(A) REQUIRED INFORMATION.—An appli-
cation submitted under this subsection shall in-
clude information demonstrating that— 
‘‘(i) the biological product is bio-
similar to a reference product based upon 
data derived from— 
‘‘(I) analytical studies that dem-
onstrate that the biological product is 
highly similar to the reference product 
notwithstanding minor differences in 
clinically inactive components; 
‘‘(II) animal studies (including 
the assessment of toxicity); and 
‘‘(III) a clinical study or studies 
(including, but not limited to, the as-
sessment of immunogenicity and phar-
macokinetics or pharmacodynamics) 
that are sufficient to demonstrate 
safety, purity, and potency for each 
condition of use for which the ref-
erence product is approved; 
‘‘(ii) the biological product and ref-
erence product utilize the same mechanism 
or mechanisms of action for the condition 
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or conditions of use prescribed, rec-
ommended, or suggested in the proposed 
labeling, but only to the extent the mecha-
nism or mechanisms of action are known 
for the reference product; 
‘‘(iii) the condition or conditions of 
use prescribed, recommended, or suggested 
in the labeling proposed for the biological 
product have been previously approved for 
the reference product; 
‘‘(iv) the route of administration, the 
dosage form, and the strength of the bio-
logical product are the same as those of 
the reference product; and 
‘‘(v) the facility in which the biological 
product 
is 
manufactured, 
processed, 
packed, or held meets standards designed 
to assure that the biological product con-
tinues to be safe, pure, and potent. 
‘‘(B) WAIVER
REGARDING
ANALYTICAL 
STUDIES, 
ANIMAL
STUDIES, 
AND
CLINICAL 
STUDIES.— 
‘‘(i) IN
GENERAL.—The Secretary 
may, in the Secretary’s discretion, deter-
mine that an element described in sub-
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clause (I), (II), or (III) of subparagraph 
(A)(i) is unnecessary and waive the re-
quirement that such element be submitted 
in an application under this subsection. 
‘‘(ii) 
ASSESSMENTS
OF 
IMMUNOGENICITY.—Notwithstanding 
clause (i), the Secretary may determine 
that an assessment of immunogenicity de-
scribed in subparagraph (A)(i)(III) is un-
necessary and waive the requirement that 
such an assessment be submitted in an ap-
plication under this subsection only if the 
Secretary has published a final guidance, 
following receipt and consideration of pub-
lic comments on a draft guidance— 
‘‘(I) advising that it is feasible in 
the current state of scientific knowl-
edge to make determinations on 
immunogenicity with respect to prod-
ucts in the product class to which the 
biological product belongs; and 
‘‘(II) explaining the data that 
will be required to support such a de-
termination. 
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‘‘(C) ADDITIONAL INFORMATION.—An ap-
plication submitted under this subsection— 
‘‘(i) shall include publicly available in-
formation regarding the Secretary’s pre-
vious determination that the reference 
product is safe, pure, and potent; and 
‘‘(ii) may include any additional infor-
mation in support of the application, in-
cluding publicly available information with 
respect to the reference product or another 
biological product. 
‘‘(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 approve the application (or the supple-
ment) if— 
‘‘(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 with respect to each condition of use 
for which the reference product is approved; 
and 
‘‘(B) the applicant (or other appropriate 
person) consents to the inspection of the facility 
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‘‘(ii) for a biological product that is 
administered more than once to an indi-
vidual, the risk of alternating or switching 
between use of the biological product and 
the reference product (in terms of safety, 
diminished efficacy, and reduced or en-
hanced potency) is not greater than the 
risk of using the reference product without 
such alternation or switching. 
‘‘(B) GUIDELINES.—Notwithstanding sub-
paragraph (A), the Secretary may not make a 
determination that a biological product licensed 
under this subsection is interchangeable with 
the reference product unless the Secretary has 
published a final guidance, following receipt and 
consideration of public comments on a draft 
guidance— 
‘‘(i) advising that it is feasible in the 
current state of scientific knowledge to 
make such determinations with respect to 
products in the product class to which that 
biological product belongs; and 
‘‘(ii) explaining the data that will be 
required to support such a determination. 
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‘‘(C) PRESERVATION OF STATE AUTHOR-
ITY.—Nothing in this subsection shall be con-
strued as preempting or otherwise affecting the 
authority of a State to require or regulate pre-
scriptions. 
‘‘(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 
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). 
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‘‘(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-
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 
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licensing such biological product under this sub-
section. 
‘‘(6) EXCLUSIVITY FOR FIRST INTERCHANGE-
ABLE BIOLOGICAL PRODUCT.—The Secretary shall 
not make a determination under paragraph (4) that 
a second or subsequent biological product is inter-
changeable with the same reference product for 
which a prior biological product has received a deter-
mination of interchangeability until 24 months after 
the later of— 
‘‘(A) the date of the first commercial mar-
keting of the first biosimilar biological product 
determined to be interchangeable for that ref-
erence product; or 
‘‘(B) with respect to a product marketed 
before the date the product is determined to be 
interchangeable, the date that the product is 
determined to be interchangeable. 
‘‘(7) EXCLUSIVITY
FOR
REFERENCE
PROD-
UCT.— 
‘‘(A) EFFECTIVE DATE OF BIOSIMILAR AP-
PLICATION
LICENSURE.—Subject to subpara-
graph (D) and paragraph (8), approval of an 
application under this subsection may not be 
made effective by the Secretary until the date 
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that is 12 years after the date on which the ref-
erence product was first licensed under sub-
section (a). 
‘‘(B) FILING
PERIOD.—An application 
under this subsection may not be submitted to 
the Secretary until the later of— 
‘‘(i) the date of commencement of a 
proceeding for issuance of guidance pursu-
ant to paragraph (9) with respect to the 
product class within which the product 
that is the subject of such application falls; 
or 
‘‘(ii) the date that is 4 years after the 
date on which the reference product was 
first licensed under subsection (a). 
‘‘(C) FIRST LICENSURE.—For purposes of 
this paragraph, the date on which the reference 
product was first licensed under subsection (a) 
does not include the date of approval of a sup-
plement or of a subsequent application for a 
new indication, route of administration, dosage 
form, or strength for the previously licensed ref-
erence product. 
‘‘(D) MEDICALLY SIGNIFICANT NEW INDI-
CATION.—If, during the 8-year period following 
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licensure of the reference product, the Secretary 
approves a supplement to the application for 
the reference product that seeks approval to 
market the reference product for a new indica-
tion that, if approved, would be a significant 
improvement, compared to marketed products, 
in the treatment, diagnosis, or prevention of 
disease, approval of an application submitted 
under this subsection may not be made effective 
by the Secretary until the date that is 14 years 
after the date on which the reference product 
was first licensed under subsection (a). 
‘‘(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 
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tablish a process through which the public 
may provide the Secretary with input re-
garding priorities for issuing guidance. 
‘‘(C) CERTAIN PRODUCT CLASSES.— 
‘‘(i) GUIDANCE.—The Secretary may 
indicate in a guidance document under 
subparagraph (A) that the Secretary will 
not license a product or product class (not 
including any recombinant protein) under 
this subsection because the science and ex-
perience, as of the date of such guidance, 
does not allow such licensure. 
‘‘(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). 
‘‘(D) PETITION FOR INITIATION OF GUID-
ANCE FOR CERTAIN PRODUCTS.—In the case of 
a reference product that was licensed by the 
Secretary more than 7 years prior to the date 
of 
the 
enactment 
of 
the 
Pathway 
for 
Biosimilars Act, a person may petition the Sec-
retary at any time to commence the process for 
issuing final guidance under subparagraph (A) 
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for the product class to which the reference 
product belongs. Any such petition shall include 
a description of the scientific feasibility and ra-
tionale for the request. For guidance petitioned 
under this subparagraph, the Secretary shall, 
within 2 years of such petition, issue final guid-
ance with respect to that product class. 
‘‘(E) REQUIREMENT
FOR
APPLICATION 
CONSIDERATION.—The Secretary may not ac-
cept an application under this subsection until 
the Secretary has initiated a proceeding for 
issuance of guidance with respect to the product 
class within which the product that is the sub-
ject of the application falls. The Secretary may 
not approve an application under this sub-
section until the Secretary has completed the 
proceeding for issuance of guidance with re-
spect to the product class within which the 
product that is the subject of the application 
falls. 
‘‘(F) REQUIREMENT FOR PRODUCT CLASS- 
SPECIFIC
GUIDANCE.—Product 
class-specific 
guidance issued under subparagraph (A) shall 
include a description of— 
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‘‘(i) the criteria that the Secretary will 
use to determine whether a biological prod-
uct is biosimilar to a reference product in 
such product class; 
‘‘(ii) the criteria, if available, that the 
Secretary will use to determine whether a 
biological product meets the standards for 
interchangeability described in paragraph 
(4); and 
‘‘(iii) the criteria, if available, that the 
Secretary 
will 
use 
to 
assess 
immunogenicity. 
‘‘(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— 
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‘‘(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— 
‘‘(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 
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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 
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-
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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). 
‘‘(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-
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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. 
‘‘(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 
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‘‘(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 
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-
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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 
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), (k)(7)(D), or 
(k)(8) the Secretary shall make approval of the ap-
plication effective on the day after the date of expi-
ration of the patent that has been found to be in-
fringed. If more than one such patent is found to be 
infringed by the court, the approval of the applica-
tion shall be made effective on the day after the date 
that the last such patent expires. 
‘‘(6) LIMITATIONS ON ACTIONS FOR DECLARA-
TORY JUDGMENT.—With respect to a patent that is 
the subject of an explanation under paragraph 
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(4)(D)(ii), no action for a declaratory judgment that 
the patent is invalid, unenforceable, or not infringed 
may be brought under section 2201 of title 28, 
United States Code, by an applicant prior to the 
date that is the later of— 
‘‘(A) 3 years prior to the date applicable 
under subsection (k)(7)(A); or 
‘‘(B) 120 days after such explanation has 
been provided.’’. 
(b) 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— 
(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 
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(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. 
(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-
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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. 102. 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. 
TITLE II—AMENDMENTS TO 
PATENT ACT 
SEC. 201. AMENDMENTS TO CERTAIN PATENT PROVISIONS. 
Section 271(e)(2) of title 35, United States Code is 
amended— 
(1) in subparagraph (A), by striking ‘‘or’’ after 
‘‘patent’’; 
(2) in subparagraph (B), by adding ‘‘or’’ after 
the comma at the end; and 
(3) by inserting the following after subpara-
graph (B): 
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‘‘(C) 
a 
statement 
under 
section 
351(l)(4)(D)(ii) of the Public Health Service 
Act,’’. 
Æ 
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