similar biological product development, bio-
similar biological product applications, and sup-
plements. 
‘‘(10) The term ‘final dosage form’ means, with 
respect to a biosimilar biological product, a finished 
dosage form which is approved for administration to 
a patient without substantial further manufacturing 
(such as lyophilized products before reconstitution). 
‘‘(11) The term ‘financial hold’— 
‘‘(A) means an order issued by the Sec-
retary to prohibit the sponsor of a clinical in-
vestigation from continuing the investigation if 
the Secretary determines that the investigation 
is intended to support a biosimilar biological 
product application and the sponsor has failed 
to pay any fee for the product required under 
subparagraph (A), (B), or (D) of section 
744H(a)(1); and 
‘‘(B) does not mean that any of the bases 
for a ‘clinical hold’ under section 505(i)(3) have 
been determined by the Secretary to exist con-
cerning the investigation. 
‘‘(12) The term ‘person’ includes an affiliate of 
such person. 
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‘‘(13) The term ‘process for the review of bio-
similar biological product applications’ means the 
following activities of the Secretary with respect to 
the review of submissions in connection with bio-
similar biological product development, biosimilar bi-
ological product applications, and supplements: 
‘‘(A) The activities necessary for the re-
view of submissions in connection with bio-
similar biological product development, bio-
similar biological product applications, and sup-
plements. 
‘‘(B) Actions related to submissions in con-
nection with biosimilar biological product devel-
opment, the issuance of action letters which ap-
prove biosimilar biological product applications 
or which set forth in detail the specific defi-
ciencies in such applications, and where appro-
priate, the actions necessary to place such ap-
plications in condition for approval. 
‘‘(C) The inspection of biosimilar biological 
product establishments and other facilities un-
dertaken as part of the Secretary’s review of 
pending biosimilar biological product applica-
tions and supplements. 
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‘‘(D) Activities necessary for the release of 
lots of biosimilar biological products under sec-
tion 351(k) of the Public Health Service Act. 
‘‘(E) Monitoring of research conducted in 
connection with the review of biosimilar biologi-
cal product applications. 
‘‘(F) Postmarket safety activities with re-
spect to biologics approved under biosimilar bio-
logical product applications or supplements, in-
cluding the following activities: 
‘‘(i) Collecting, developing, and re-
viewing safety information on biosimilar bi-
ological products, including adverse event 
reports. 
‘‘(ii) Developing and using improved 
adverse-event data-collection systems, in-
cluding information technology systems. 
‘‘(iii) Developing and using improved 
analytical tools to assess potential safety 
problems, including access to external data 
bases. 
‘‘(iv) Implementing and enforcing sec-
tion 505(o) (relating to postapproval stud-
ies and clinical trials and labeling changes) 
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and section 505(p) (relating to risk evalua-
tion and mitigation strategies). 
‘‘(v) Carrying out section 505(k)(5) 
(relating to adverse event reports and 
postmarket safety activities). 
‘‘(14) The term ‘supplement’ means a request 
to the Secretary to approve a change in a biosimilar 
biological product application which has been ap-
proved, including a supplement requesting that the 
Secretary determine that the biosimilar biological 
product meets the standards for interchangeability 
described in section 351(k)(4) of the Public Health 
Service Act. 
‘‘SEC. 744H. AUTHORITY TO ASSESS AND USE BIOSIMILAR 
BIOLOGICAL PRODUCT FEES. 
‘‘(a) TYPES
OF FEES.—Beginning in fiscal year 
2013, the Secretary shall assess and collect fees in accord-
ance with this section as follows: 
‘‘(1) 
BIOSIMILAR
DEVELOPMENT
PROGRAM 
FEES.— 
‘‘(A) 
INITIAL
BIOSIMILAR
BIOLOGICAL 
PRODUCT DEVELOPMENT FEE.— 
‘‘(i) IN GENERAL.—Each person that 
submits to the Secretary a meeting request 
described under clause (ii) or a clinical 
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protocol for an investigational new drug 
protocol described under clause (iii) shall 
pay for the product named in the meeting 
request or the investigational new drug ap-
plication the initial biosimilar biological 
product development fee established under 
subsection (b)(1)(A). 
‘‘(ii) MEETING REQUEST.—The meet-
ing request defined in this clause is a re-
quest for a biosimilar biological product 
development meeting for a product. 
‘‘(iii) CLINICAL PROTOCOL FOR IND.— 
A clinical protocol for an investigational 
new drug protocol described in this clause 
is a clinical protocol consistent with the 
provisions of section 505(i), including any 
regulations promulgated under section 
505(i), (referred to in this section as ‘in-
vestigational new drug application’) de-
scribing an investigation that the Secretary 
determines is intended to support a bio-
similar biological product application for a 
product. 
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‘‘(iv) DUE
DATE.—The initial bio-
similar biological product development fee 
shall be due by the earlier of the following: 
‘‘(I) Not later than 5 days after 
the Secretary grants a request for a 
biosimilar biological product develop-
ment meeting. 
‘‘(II) The date of submission of 
an investigational new drug applica-
tion describing an investigation that 
the Secretary determines is intended 
to support a biosimilar biological 
product application. 
‘‘(v) TRANSITION
RULE.—Each per-
son that has submitted an investigational 
new drug application prior to the date of 
enactment of the Biosimilars User Fee Act 
of 2012 shall pay the initial biosimilar bio-
logical product development fee by the ear-
lier of the following: 
‘‘(I) Not later than 60 days after 
the date of the enactment of the 
Biosimilars User Fee Act of 2012, if 
the Secretary determines that the in-
vestigational new drug application de-
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scribes an investigation that is in-
tended to support a biosimilar biologi-
cal product application. 
‘‘(II) Not later than 5 days after 
the Secretary grants a request for a 
biosimilar biological product develop-
ment meeting. 
‘‘(B) ANNUAL
BIOSIMILAR
BIOLOGICAL 
PRODUCT DEVELOPMENT FEE.— 
‘‘(i) IN
GENERAL.—A person that 
pays an initial biosimilar biological product 
development fee for a product shall pay for 
such product, beginning in the fiscal year 
following the fiscal year in which the initial 
biosimilar biological product development 
fee was paid, an annual fee established 
under subsection (b)(1)(B) for biosimilar 
biological product development (referred to 
in this section as ‘annual biosimilar bio-
logical product development fee’). 
‘‘(ii) DUE
DATE.—The annual bio-
similar biological product development pro-
gram fee for each fiscal year will be due on 
the later of— 
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