Assessing User Fees 
Under the Biosimilar 
User Fee Amendments 
of 2022 
Guidance for Industry 
 
FINAL GUIDANCE  
 
 
 
 
 
 
 
 
 
 
 
 
 
U.S. Department of Health and Human Services 
Food and Drug Administration 
Center for Drug Evaluation and Research (CDER) 
Center for Biologics Evaluation and Research (CBER) 
 
July 2023 
User Fees  Assessing User Fees 
Under the Biosimilar 
User Fee Amendments 
of 2022 
Guidance for Industry 
 
Additional copies are available from: 
 
Office of Communications, Division of Drug Information 
Center for Drug Evaluation and Research 
Food and Drug Administration 
10001 New Hampshire Ave., Hillandale Bldg., 4th Floor  
Silver Spring, MD  20993-0002  
Phone: 855-543-3784 or 301-796-3400; Fax: 301-431-6353;  
Email: druginfo@fda.hhs.gov 
https://www.fda.gov/drugs/guidance-compliance-regulatory-information/guidances-drugs 
and/or 
Office of Communication, Outreach, and Development  
Center for Biologics Evaluation and Research 
Food and Drug Administration 
10903 New Hampshire Ave., Bldg. 71, Room 3128 
Silver Spring, MD  20993-0002 
Phone: 800-835-4709 or 240-402-8010  
Email: ocod@fda.hhs.gov 
https://www.fda.gov/vaccines-blood-biologics/guidance-compliance-regulatory-information-biologics/biologics-guidances 
 
 
U.S. Department of Health and Human Services 
Food and Drug Administration 
Center for Drug Evaluation and Research (CDER) 
Center for Biologics Evaluation and Research (CBER) 
 
July 2023 
User Fees 
   
TABLE OF CONTENTS 
 
I.  INTRODUCTION............................................................................................................. 1 
II.  BACKGROUND ............................................................................................................... 1 
III.  DEFINITIONS .................................................................................................................. 2 
IV.  STRUCTURE OF THE BSUFA USER FEE PROGRAM ........................................... 3 
V.  BIOSIMILAR BIOLOGICAL PRODUCT DEVELOPMENT FEES ........................ 3 
A.  Initial BPD Fee ............................................................................................................................... 3 
B.  Annual BPD Fee ............................................................................................................................. 4 
C.  Request for Refund of Annual BPD Fee ...................................................................................... 4 
D.  Discontinuation of Annual BPD Fee Obligation ......................................................................... 5 
E.  Reactivation Fee ............................................................................................................................. 6 
VI.  BIOSIMILAR BIOLOGICAL PRODUCT APPLICATION FEES ............................ 7 
A.  Exception to the Application Fee .................................................................................................. 7 
B.  Applications Refused for Filing or Withdrawn ........................................................................... 7 
C.  Waiver of the Application Fee ...................................................................................................... 8 
1. Small Business Waiver and Return Request .................................................................................... 8 
2. Expiration Date of the Small Business Waiver ................................................................................ 9 
3. Small Business Waivers of Application Fees for Future Biosimilar Biological Product 
Applications .......................................................................................................................................... 9 
VII.  BIOSIMILAR BIOLOGICAL PRODUCT PROGRAM FEES................................. 10 
A.  Program Fees for Liquid Parenteral Biosimilar Biological Products ..................................... 10 
VIII.  FAILURE TO PAY FEES.............................................................................................. 11 
IX.  PAYMENT INFORMATION AND PROCEDURES ................................................. 12 
A.  Initial BPD Fees, Reactivation Fees, and Application Fees ...................................................... 12 
B.  Annual Billing Cycle .................................................................................................................... 12 
X.  APPEALS PROCESS ..................................................................................................... 14 
A.  Reconsideration Request ............................................................................................................. 14 
B.  Appeal Request ............................................................................................................................ 14 
XI.  OTHER RESOURCES ................................................................................................... 15 
XII.  PAPERWORK REDUCTION ACT OF 1995 .............................................................. 16  Contains Nonbinding Recommendations 
 
Assessing User Fees Under the Biosimilar User Fee  
Amendments of 2022 
Guidance for Industry1 
 
 
 
 
This guidance represents the current thinking of the Food and Drug Administration (FDA or Agency) on 
this topic.  It does not establish any rights for any person and is not binding on FDA or the public.  You 
can use an alternative approach if it satisfies the requirements of the applicable statutes and regulations.  
To discuss an alternative approach, contact the FDA staff responsible for this guidance as listed on the 
title page. 
 
 
 
I.  INTRODUCTION  
 
This guidance provides information to stakeholders regarding FDAs implementation of the 
Biosimilar User Fee Amendments of 2022 (BsUFA III) under Title IV of the FDA User Fee 
Reauthorization Act of 2022. 
 
This guidance describes the types of user fees authorized by BsUFA III, how FDA determines 
which products are subject to a fee, and FDAs policies regarding exceptions and waivers.  This 
guidance also describes the process for submitting payments to FDA and the consequences for 
failing to pay BsUFA fees, and the process for requesting reconsideration if FDA denies a 
request for a waiver or return of user fees.  This guidance does not address FDAs 
implementation of other user fee programs (e.g., Prescription Drug User Fee Amendments, 
Generic Drug User Fee Amendments).  Throughout this guidance, references to user fees or the 
user-fee program are specific to the biosimilar biological product user fee program under section 
744H of the Federal Food, Drug, and Cosmetic Act (FD&C Act). 
 
In general, FDAs guidance documents do not establish legally enforceable responsibilities.  
Instead, guidances describe the Agencys current thinking on a topic and should be viewed only 
as recommendations unless specific regulatory or statutory requirements are cited.  The use of 
the word should in Agency guidances means that something is suggested or recommended, but 
not required.  
 
 
II.  BACKGROUND 
 
 
1 This guidance has been prepared by the Division of User Fee Management, Office of Management, in the Center 
for Drug Evaluation and Research in cooperation with the Center for Biologics Evaluation and Research at the Food 
and Drug Administration.  Submit comments to Docket No. FDA-2017-D-6821 (available at 
https://www.regulations.gov/docket?D=FDA-2017-D-6821).  See the instructions in that docket for submitting 
comments on this and other Level 2 guidances. 
  1  Contains Nonbinding Recommendations 
 
The Biosimilar User Fee Act of 2012 (BsUFA I) added sections 744G and 744H to the FD&C 
Act, authorizing FDA to collect user fees for a 5-year period from persons that develop 
biosimilar biological products.  Since 2012, Congress has revised and extended BsUFA two 
times, each time for a 5-year period.  Fees authorized by this legislation help fund the process for 
the review of biosimilar biological product applications and have played an important role in 
expediting the review and approval process.  The most recent reauthorization (known as BsUFA 
III) is under Title IV of the FDA User Fee Reauthorization Act of 2022, enacted on September 
30, 2022.   
 
BsUFA III extends FDAs authority to collect user fees from Fiscal Year (FY) 2023 through FY 
2027.2  Discussions about the next reauthorization of BsUFA are expected to begin before FY 
2027, the final fiscal year of BsUFA III. 
 
 
III.  DEFINITIONS 
 
For purposes of this guidance: 
 
  The term affiliate means a business entity that has a relationship with a second business 
entity if, directly or indirectly, (A) one business entity controls, or has the power to 
control, the other business entity, or (B) a third-party controls, or has the power to 
control, both of the business entities.3 
 
  The term biosimilar biological product means a specific strength of a biological product 
in final dosage form for which a biosimilar biological product application has been 
approved.4 
 
  Except as provided by section 744G(4)(B), the term biosimilar biological product 
application means an application for licensure of a biological product under section 
351(k) of the Public Health Service Act (PHS Act).5 
 
  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).6 
 
  The term financial hold means an order issued by the Secretary to prohibit the sponsor of 
a clinical investigation 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 of the biosimilar biological product development program 
fees for the product.7 
 
2 FDAs fiscal year begins on October 1 and ends on September 30. 
3 Section 744G(2) of the FD&C Act. 
4 Section 744G(3) of the FD&C Act. 
5 Section 744G(4)(A) of the FD&C Act. 
6 Section 744G(10) of the FD&C Act. 
7 Section 744G(11) of the FD&C Act. 
  2  Contains Nonbinding Recommendations 
 
 
  The term person includes an affiliate of such person.8  The term person includes an 
individual, partnership, corporation, or association.9  This document will also use the 
term person when referring to a sponsor or applicant. 
 
  The term supplement means a request to the Secretary to approve a change in a 
biosimilar biological product application which has been approved, 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 PHS 
Act.10 
 
 
IV.  STRUCTURE OF THE BSUFA USER FEE PROGRAM 
 
BsUFA III authorizes the collection of three types of fees: (1) biosimilar biological product 
development program fees (BPD fees), (2) biosimilar biological product application fees 
(application fees), and (3) biosimilar biological product program fees (program fees). 
 
The Agency will establish initial and annual BPD fees and reactivation fees, biosimilar 
biological product application fees, and biosimilar biological product program fees for each 
fiscal year following a process set forth in the statute and will publish the fees and fee revenue 
amounts for a fiscal year in the Federal Register not later than 60 days before the start of that 
year.11 
 
 
V.  BIOSIMILAR BIOLOGICAL PRODUCT DEVELOPMENT FEES 
 
BsUFA III BPD fees are assessed for products in FDAs BPD program.  BPD fees include the 
initial BPD fee, the annual BPD fee, and the reactivation fee.   
 
A.  Initial BPD Fee 
 
Under section 744H(a)(1)(A) of the FD&C Act, an initial BPD fee is a one-time fee that is 
assessed to a sponsor to enter the BPD program.  To enter the BPD program for a product, a 
sponsor can:  
 
  Request a BPD meeting for a product; or 
 
  Submit a clinical protocol for an investigational new drug application (IND) 
describing an investigation that FDA determines is intended to support a biosimilar 
biological product application for the product. 
 
 
8 Section 744G(12) of the FD&C Act. 
9 Section 201(e) of the FD&C Act, 21 U.S.C. 321(e). 
10 Section 744G(14) of the FD&C Act. 
11 Section 744H(c)(5) of the FD&C Act. 
  3  Contains Nonbinding Recommendations 
 
There is no fee for a biosimilar initial advisory meeting. 
 
The initial BPD fee is due within 7 calendar days after FDA grants the first BPD meeting for the 
product or upon submission of an IND for the product that FDA determines is intended to 
support a biosimilar biological product application, whichever occurs first.12  Refer to section 
VIII of this guidance for consequences of failing to pay the required fees.   
 
B.  Annual BPD Fee 
 
Beginning in the next fiscal year after a sponsor has paid the initial BPD fee, the sponsor must 
pay an annual BPD fee13 for the product in each fiscal year.14  The annual BPD fee for a product 
is due on the first business day on or after October 1 of each fiscal year15 or the first business day 
after the enactment of an appropriations Act providing for the collection and obligation of such 
fees for the year, whichever is later, unless:  
 
  The sponsor has submitted a marketing application for the product that was 
accepted for filing;16 
 
  The sponsor has discontinued participation in the BPD program for the product;17 
or 
 
  The sponsor has been administratively removed from the BPD program for the 
product.18 
 
C.  Request for Refund of Annual BPD Fee 
 
If a person submits a biosimilar biological product application before October 1 of the fiscal year 
and the application is subsequently accepted for filing, the person may request a refund of the 
annual BPD fee paid by the person for such fiscal year.19  To qualify for consideration for such a 
refund, the person must submit to FDA a written request for the refund not later than 180 
calendar days after the application is accepted for filing.20 
 
 
12 Section 744H(a)(1)(A)(iv) of the FD&C Act. 
13 Section 744H(a)(1)(B) of the FD&C Act. 
14 In the case that such product (including, where applicable, ownership of the relevant IND) is transferred to a 
licensee, assignee, or successor of the person that paid the initial BPD fee for the product, and written notice of such 
transfer is provided to FDA, such licensee, assignee, or successor must pay the annual BPD fee. Section 
744H(a)(1)(B)(i) of the FD&C Act. 
15 Section 744H(a)(1)(B)(ii) of the FD&C Act. 
16 Section 744H(a)(1)(B)(iii)(I) of the FD&C Act. 
17 Section 744H(a)(1)(B)(iii)(II) of the FD&C Act. 
18 Section 744H(a)(1)(B)(iii)(III) of the FD&C Act. 
19 Section 744H(a)(1)(B)(iv) of the FD&C Act. 
20 Id. 
  4  Contains Nonbinding Recommendations 
 
For example, if a person is in the BPD program and receives an invoice for the annual BPD fee 
for FY 2023,21 the person may request a refund of the annual BPD fee paid for FY 2023 if a 
biosimilar biological product application for the product was submitted in FY 2022 and accepted 
for filing.  To qualify for consideration for a refund of the annual BPD fee paid for the product 
for FY 2023, the person must submit to FDA a written request for the refund not later than 180 
calendar days from the date the application was accepted for filing.  The person should submit 
Form FDA 3913 (User Fee Payment Refund Request)22 to CDERCollections@fda.hhs.gov to 
request such refund.   
 
D.  Discontinuation of Annual BPD Fee Obligation 
 
A sponsor may discontinue participation in the BPD program for a product, effective October 1 
of a fiscal year, by notifying FDA on or before August 1 of the preceding fiscal year as 
follows:23 
 
  If the sponsor has not yet submitted an IND  By submitting a written declaration to FDA 
that the sponsor has no present intention of further developing the product as a biosimilar 
biological product.24  The sponsor should send a courtesy copy to 
CDERCollections@fda.hhs.gov and include the following information in the letter: 
 
  Sponsors contact information including name, address, email, and telephone 
o
number 
  Identification of the request at the top of the cover letter as Request to 
o
Discontinue Participation in the BPD Program 
  Name of product 
o
  Pre-IND number 
o
 
  If the sponsor has already submitted an IND and wishes to discontinue participation in 
the BPD program  By withdrawing the IND for the product in accordance with Part 312 
of Title 21 of the Code of Federal Regulations (CFR) or any successor regulations.25   
 
In addition to withdrawing the IND, the sponsor should submit to FDA a written request 
to discontinue participation in the BPD program, as described above, with a courtesy 
copy to CDERCollections@fda.hhs.gov.  
 
Requests to discontinue participation in the BPD program can be submitted to the FDA 
Electronic Submissions Gateway26 or mailed to: 
 
Food and Drug Administration 
 
21 In this example, the fee for FY 2023 would be due on the first business day on or after October 1, 2022 (unless 
one of the exceptions applies; see section V.B of this guidance). 
22 FDA Form 3913, available at https://www.fda.gov/ForIndustry/UserFees/. 
23 Section 744H(a)(1)(C) of the FD&C Act. 
24 Section 744H(a)(1)(C)(i) of the FD&C Act. 
25 Section 744H(a)(1)(C)(ii) of the FD&C Act. 
26 https://www.fda.gov/industry/electronic-submissions-gateway. 
  5  Contains Nonbinding Recommendations 
 
Center for Drug Evaluation and Research 
Central Document Room 
5901-B Ammendale Road 
Beltsville, MD 20705-1266 
 
FDA must receive the request by August 1 of the preceding fiscal year to avoid assessment of the 
annual BPD fee.27  If FDA receives a request to discontinue participation in the BPD program 
after August 1 of the fiscal year, the sponsor will receive an annual BPD fee invoice for the 
upcoming fiscal year and must pay the invoice amount by the due date.28  Under section 
744H(a)(1)(F)(i) of the FD&C Act, FDA shall not refund any BPD fee (initial, annual, or 
reactivation), except as provided in section 744H(a)(1)(B)(iv) of the FD&C Act (see section V.C. 
of this guidance).  
 
E.  Reactivation Fee 
 
A sponsor that has discontinued participation in the BPD program for a product or has been 
administratively removed from the BPD program for a product and wants to resume participation 
in the BPD program for the product must pay all annual BPD fees previously assessed for such 
product and still owed and a reactivation fee.29  To resume participation in the BPD program for 
a product, a sponsor can: 
 
  Request a BPD meeting for the product; or 
 
  Submit a clinical protocol for an IND describing an investigation that FDA 
determines is intended to support a biosimilar biological product application for the 
product. 
 
The reactivation fee is due within 7 calendar days after FDA grants a BPD meeting for the 
product or upon submission of an IND describing an investigation that FDA determines is 
intended to support a biosimilar biological product application for the product, whichever occurs 
first.30  The reactivation fee for a fiscal year will be equal to twice the amount of the annual BPD 
fee established for that fiscal year.31  Refer to section VIII of this guidance for consequences of 
failing to pay the required fees. 
 
Beginning in the next fiscal year after a sponsor has paid the reactivation fee for a product, the 
sponsor must pay an annual BPD fee for such product.32   
 
 
 
27 Section 744H(a)(1)(C) of the FD&C Act. 
28 Sections 744H(a)(1)(B) and 744H(a)(1)(C) of the FD&C Act. 
29 Section 744H(a)(1)(D) of the FD&C Act. 
30 Section 744H(a)(1)(D)(i) of the FD&C Act. 
31 Section 744H(b)(2)(C) of the FD&C Act. 
32 In the case that such product (including, where applicable, ownership of the relevant IND) is transferred to a 
licensee, assignee, or successor of the person that paid the reactivation fee for the product, and written notice of such 
transfer is provided to FDA, such licensee, assignee, or successor must pay the annual BPD fee.  Section 
744H(a)(1)(D)(ii) of the FD&C Act. 
  6  Contains Nonbinding Recommendations 
 
VI.  BIOSIMILAR BIOLOGICAL PRODUCT APPLICATION FEES 
 
FDA assesses a user fee for each biosimilar biological product application.  Each person that 
submits a biosimilar biological product application is assessed an application fee as follows: 
 
  A biosimilar biological product application for which clinical data (other than 
comparative bioavailability studies) with respect to safety or effectiveness are required 
for approval is assessed a full application fee.33 
 
  A biosimilar biological product application for which clinical data (other than 
comparative bioavailability studies) with respect to safety or effectiveness are not 
required for approval is assessed one-half of a full application fee.34 
 
Application fees are due when the application is submitted.35 
 
A.  Exception to the Application Fee 
 
If a biosimilar biological product application: 
 
  was submitted by a person that paid the fee for the application; 
 
  was accepted for filing; and 
 
  was not approved or was withdrawn prior to approval (without a waiver), 
 
the submission of a biosimilar biological product application for the same product by the same 
person (or the persons licensee, assignee, or successor) does not require an application fee.36 
 
B.  Applications Refused for Filing or Withdrawn 
 
If an application is refused for filing by the FDA or is withdrawn by the applicant without a 
waiver before filing, FDA will refund 75 percent of the paid application fee.37  A written refund 
request is not required.   
 
An application that was withdrawn before filing or refused for filing shall be subject to the full 
application fee when resubmitted or filed over protest unless a waiver applies.38 
 
 
33 Section 744H(a)(2)(A)(i) of the FD&C Act. 
34 Section 744H(a)(2)(A)(ii) of the FD&C Act. 
35 Section 744H(a)(2)(C) of the FD&C Act. 
36 Section 744H(a)(2)(D) of the FD&C Act. 
37 Section 744H(a)(2)(E) of the FD&C Act. 
38 Section 744H(a)(2)(F) of the FD&C Act. 
  7  Contains Nonbinding Recommendations 
 
C.  Waiver of the Application Fee 
 
Under section 744H(d)(1) of the FD&C Act, an applicant is eligible for a waiver of the 
application fee if the applicant is a small business submitting its first biosimilar biological 
product application to the Agency for review and does not have another product that has been 
approved under a human drug application39 or a biosimilar biological product application and 
introduced or delivered for introduction into interstate commerce. 
 
To qualify for a small business waiver of the application fee, an applicant must meet all of the 
following criteria: 
 
  The applicant employs fewer than 500 employees, including employees of affiliates; 
 
  The applicant does not have a drug product that has been approved under a human drug 
application or a biosimilar biological product application and introduced or delivered for 
introduction into interstate commerce; and 
 
  The applicant, including its affiliates, is submitting its first biosimilar biological product 
application. 
 
1.  Small Business Waiver and Return Request 
 
To qualify for a small business waiver of the biosimilar biological product application fee,40 an 
applicant should submit to the Agency Form FDA 397141 at least four months prior to the 
submission of the application.  If an applicant submitted an application with payment and would 
like to request a small business waiver and return of the fee paid, the applicant should complete 
and submit Form FDA 3971 to request the return.  Such a request must be made not later than 
180 calendar days of when the application fee was due.42  The completed form should be 
submitted via email to CDERCollections@fda.hhs.gov. 
 
Upon receipt of Form FDA 3971, FDA may contact the applicant to request additional 
information and to clarify information provided in Form FDA 3971.  Examples of information 
that may be requested include, but are not limited to, the following: 
 
  An application for size determination; 
 
  A copy of the applicants Articles of Incorporation and Bylaws; 
 
  The applicants most recent annual financial statement to shareholders; and 
 
 
39 Section 735(1) of the FD&C Act; 21 U.S.C. 379(g)(1). 
40 Section 744H(d)(1) of the FD&C Act.   
41 FDA Form 3971, available at https://www.fda.gov/media/108984/download. 
42 Section 744H(h) of the FD&C Act. 
  8  Contains Nonbinding Recommendations 
 
  A breakdown of the number of persons employed full time, part time, temporarily, or 
otherwise by the applicant and affiliates during each of the pay periods for the 12 months 
preceding the applicants certification. 
 
Occasionally, FDA finds entities affiliated with the applicant that were not identified by the 
applicant.  In such cases, FDA may request additional information and documents regarding the 
nature of the relationship between the applicant and such other entities.  If the requested 
information is not submitted, FDA may deny the small business waiver request because there is 
insufficient evidence that the applicant meets the criteria described in section 744H(d)(1) of the 
FD&C Act.   
 
FDA recognizes that some information provided by companies may be confidential.  FDA will 
treat confidential commercial or financial information consistent with applicable federal laws 
and regulations. 
 
After FDA assesses an applicants eligibility for a small business waiver, FDA notifies the 
applicant whether the waiver is granted. 
 
2.  Expiration Date of the Small Business Waiver 
 
If a small business waiver is granted, the applicant should submit its biosimilar biological 
product application within 1 year after the date of the small business determination since 
circumstances supporting a small business waiver may have changed.  For example, an applicant 
may have merged with a larger company and therefore no longer be considered a small business.  
Similarly, an applicant could purchase a new drug application (NDA) or biologics license 
application (BLA) from an unaffiliated company and, therefore, have a drug product that has 
been approved under a human drug application or a biosimilar biological product application and 
introduced into or delivered for introduction into interstate commerce. 
 
If an applicant is granted a small business waiver and is unable to submit the application within 1 
year of the determination, the applicant should request a new small business waiver.  The 
Agency will examine its records, including any new information submitted, to confirm that the 
applicant still meets the criteria for a small business waiver.  If the criteria are no longer met, the 
small business waiver request will be denied.  If the criteria are still met, the Agency will renew 
the small business waiver for another year. 
 
3.  Small Business Waivers of Application Fees for Future Biosimilar Biological 
Product Applications 
 
After an applicant or its affiliate(s) is granted a small business waiver and submits its first 
biosimilar biological product application, the applicant cannot receive another small business 
waiver.43  That means the applicant or its affiliate(s) is not eligible to receive a small business 
waiver for any subsequent biosimilar biological product application.  In addition, the applicant or 
affiliate(s) is ineligible for another small business waiver even if the application is withdrawn or 
 
43 Section 744H(d)(1) of the FD&C Act. 
  9  Contains Nonbinding Recommendations 
 
refused for filing.  If an applicant does not submit the application for which it was granted a 
small business waiver, the applicant may qualify again for a small business waiver.   
 
 
VII.  BIOSIMILAR BIOLOGICAL PRODUCT PROGRAM FEES  
 
The biosimilar biological product program fee (program fee) is assessed annually for each 
eligible biosimilar biological product.  Program fees are assessed for a fiscal year to each person 
who is named as the applicant in a biosimilar biological product application for each biosimilar 
biological product that is identified in a biosimilar biological product application approved as of 
October 1 of such fiscal year,44 that may be dispensed only under prescription pursuant to section 
503(b) of the FD&C Act,45 and that does not appear on a list of discontinued biosimilar 
biological products (as of October 1 of such fiscal year).46,47  For example, if the approval of a 
biosimilar biological product application occurs on or before October 1, 2022, and the products 
identified in the approved application are prescription products that do not appear on the 
discontinued list as of October 1, 2022, then program fees will be assessed for the products for 
FY 2023.  However, if approval of a biosimilar biological product application occurs after 
October 1, 2022, then program fees are not assessed for the products identified in the application 
for FY 2023. 
 
The program fees are generally due on the first business day on or after October 1 of each fiscal 
year or the first business day after the enactment of an appropriations Act providing for the 
collection and obligation of such fees for the year, whichever is later.48 
 
Applicants may not be assessed more than five program fees for biosimilar biological products 
identified in each approved application for each fiscal year.49  For example, if seven biosimilar 
biological products are approved under the same BLA, the applicant would be assessed five 
program fees for the fiscal year. 
 
A.  Program Fees for Liquid Parenteral Biosimilar Biological Products50    
 
For the purposes of assessing program fees for liquid parenteral biosimilar biological products, 
FDA intends to take into consideration both the total quantity of drug substance in mass or units 
of activity in a product and the concentration of the drug substance in mass or units of activity 
per unit volume of product.  For example, two biosimilar biological products in final dosage 
form with the same concentration but with different fill volumes would be considered two 
 
44 Section 744H(a)(3)(A)(i) of the FD&C Act. 
45 Section 744H(a)(3)(A)(ii) of the FD&C Act. 
46 Section 744H(a)(3)(A)(iii) of the FD&C Act. 
47 An approved biosimilar biological product that appears on the list of discontinued biosimilar biological products 
as of October 1 of a fiscal year would also be assessed the program fee if it is removed from the discontinued list 
during the fiscal year and the other statutory criteria for fee assessment are satisfied (see section 744H(a)(3)(E)(iii) 
of the FD&C Act).  Such fee is due on the last business day of such fiscal year and must be paid only once for each 
such product for each fiscal year.  Id. 
48 Section 744H(a)(3)(B) of the FD&C Act. 
49 Section 744H(a)(3)(D) of the FD&C Act. 
50 Section 744G(3) of the FD&C Act. 
  10  Contains Nonbinding Recommendations 
 
separate biosimilar biological products for the purpose of assessing program fees.  The applicant 
would be assessed two program fees for these products.  If the applicant has more than five 
concentrations or fill volumes approved in the BLA, it will not be assessed more than five 
program fees for each fiscal year for products identified in such application.   
 
An auto-injector that has the same strength or potency in final dosage form as a prefilled syringe 
or vial will generally be assessed a separate program fee.  This is intended to align the Agencys 
assessment of fees for biological products approved under section 351(k) of the PHS Act with its 
assessment of fees for products approved under section 351(a) of the PHS Act or section 505 of 
the FD&C Act.51, 52 
 
 
VIII.  FAILURE TO PAY FEES  
 
Under section 744H(a)(1)(E) of the FD&C Act, if a sponsor has failed to pay any BPD fee 
(initial, annual, or reactivation) for a product as required: 
 
  FDA shall not provide a BPD meeting relating to the product for which fees are owed.53 
   
  Except in extraordinary circumstances, FDA shall not consider an IND submitted for the 
product to have been received under section 505(i)(2) of the FD&C Act if FDA 
determines that the investigation is intended to support a biosimilar biological product 
application.54 
 
  Except in extraordinary circumstances, FDA shall prohibit the sponsor of a clinical 
investigation from continuing the investigation (this is referred to as a financial hold) if 
FDA determines that the investigation is intended to support a biosimilar biological 
product application.55 
 
If a sponsor has failed to pay the annual BPD fee as required for a product for a period of two 
consecutive fiscal years, FDA may administratively remove the sponsor from the BPD Program 
for the product.  FDA will provide written notice to the sponsor of the intended administrative 
removal at least 30 days prior to administratively removing the sponsor from the biosimilar 
biological product development program for the product.56   
 
A biosimilar biological product application or supplement submitted by an applicant subject to 
BsUFA fees shall be considered incomplete and shall not be accepted for filing until all BsUFA 
fees owed by such person have been paid.57 
 
51 See guidance for industry Assessing User Fees Under the Prescription Drug User Fee Amendments of 2022 
(https://www.fda.gov/media/167877/download). 
52 The distinction in this guidance between (1) auto-injectors and (2) prefilled syringes or vials is for the purposes of 
assessing the biosimilar biological product program fee only and not for any other purpose. 
53 Section 744H(a)(1)(E)(i) of the FD&C Act. 
54 Section 744H(a)(1)(E)(ii) of the FD&C Act. 
55 Section 744H(a)(1)(E)(iii) of the FD&C Act. 
56 Section 744H(a)(1)(E)(v) of the FD&C Act. 
57 Sections 744H(a)(1)(E)(iv) and 744H(e) of the FD&C Act. 
  11  Contains Nonbinding Recommendations 
 
 
 
IX.  PAYMENT INFORMATION AND PROCEDURES 
 
This section briefly describes the procedures for payment of fees and assessing and issuing 
invoices for the annual BPD fee and the biosimilar biological product program fees under 
BsUFA III.  More detailed instructions will be provided in FDAs direct notice to affected 
persons by issuing a Notification of Annual BsUFA Fees correspondence. 
 
A.  Initial BPD Fees, Reactivation Fees, and Application Fees 
 
Persons should complete a Biosimilar User Fee Cover Sheet (Form FDA 3792) online and pay 
by electronic check, wire transfer, money order, or bank draft.  Instruction on accessing and 
completing the Biosimilar User Fee Cover Sheet is located on the BsUFA website 
(https://www.fda.gov/bsufa).   
 
B.  Annual Billing Cycle 
   
1.  BsUFA Annual Survey 
 
FDA intends to send persons an annual survey to gather pertinent information to assist with fee 
setting for the next fiscal year.  FDA anticipates sending the survey in the second quarter of each 
fiscal year. 
 
2.  Notification of Annual BsUFA Fees Correspondence 
 
FDA intends to issue a Notification of Annual BsUFA Fees correspondence to affected 
persons by July of each year regarding their active BPD programs and approved biosimilar 
biological products.  Persons should review the correspondence and notify FDA of any changes 
in contact information, changes in the status of Pre-IND/INDs in the BPD program, changes in 
biosimilar biological product marketing status, and any other information pertinent for the 
Agency to issue an accurate invoice to the proper person.  
 
3.  Annual Invoicing 
 
FDA intends to issue annual invoices for the upcoming fiscal year by the preceding September, 
based on information available to the Agency at the time the invoices are prepared.  Because 
persons are invoiced for annual BPD fees and program fees in advance of the first business day 
of the upcoming fiscal year, the invoices may not reflect the actual data available as of October 
1.  FDA intends to issue additional invoices at a later date, as needed, to capture any new 
biosimilar biological products in the BPD program and program fee-eligible biosimilar 
biological products that were not previously invoiced. For example: 
 
  If a sponsor pays the FY 2022 initial BPD fee between the date the annual BPD invoices 
for FY 2023 are prepared and October 1, 2022, the sponsor can expect to receive the FY 
2023 annual BPD fee invoice in December 2022.  
  12  Contains Nonbinding Recommendations 
 
 
  An applicant with a program fee-eligible biosimilar biological product approved between 
the date that FY 2023 annual invoices are prepared and October 1, 2022, can expect to 
receive the FY 2023 program fee invoice in December 2023.  
 
  If an approved biosimilar biological product is removed from the list of discontinued 
biosimilar biological products between the date that FY 2023 annual invoices are 
prepared and the end of FY 2023, an applicant can expect to receive the FY 2023 
program fee invoice in December 2023.58 
 
Invoices may also be issued after the close of the fiscal year for other reasons.  Payment 
instructions are included on the invoice. 
 
4.  Moving a Product to the Discontinued Section of the Biosimilar Biological Product 
List 
 
FDA maintains a list of approved biosimilar biological products that are user fee-eligible and 
products that are not marketed (discontinued).  This list, Therapeutic Biosimilar Biological 
Products, is available on the BsUFA website (https://www.fda.gov/bsufa).  Applicants who 
have decided to withdraw a product from sale or have decided to delay launch of a product after 
its approval date should request to have the product moved to the discontinued section of this list 
(i.e., the list of discontinued biosimilar biological products).   
 
Requests to move an approved biosimilar biological product to the discontinued section of the 
biosimilar biological product list should be submitted to CDERCollections@fda.hhs.gov no later 
than September 30 of the preceding fiscal year.  The request should clearly identify the 
product to be moved and the date that it is or will be withdrawn from sale and, if applicable, the 
date the applicant intends to resume commercial marketing.  If the applicant submits a written 
request to place a product on the list of discontinued biosimilar biological products, and the 
request identifies the date the product is, or will be, withdrawn from sale, then for purposes of 
assessing the program fee, FDA will consider the product to have been moved to such 
discontinued list on the date that the request was received or, if the product will be withdrawn 
from sale on a future date, such future date when the product is withdrawn from sale, whichever 
is later.59  A product is considered withdrawn from sale once the applicant has ceased its own 
distribution of the product, whether or not the applicant has ordered recall of all previously 
distributed lots of the product, except that a routine, temporary interruption in supply will not 
render a product withdrawn from sale.60 
 
When requesting to move an approved biosimilar biological product to the list of discontinued 
biosimilar biological products, applicants should not rely on communications with a review 
division or other FDA components other than the CDER or CBER User Fee staff, as appropriate.   
 
 
58 Please note the applicant may also be responsible for paying FY 2022 program fees for this biosimilar biological 
product.  See FN 47. 
59 Section 744H(a)(3)(E)(i) of the FD&C Act. 
60 Section 744H(a)(3)(E)(ii) of the FD&C Act. 
  13  Contains Nonbinding Recommendations 
 
 
X.  APPEALS PROCESS 
 
A.  Reconsideration Request 
 
If FDA denies a request for a waiver or return of user fees, the applicant may request 
reconsideration of that decision.  A request for reconsideration should be made within 30 
calendar days of the issuance of FDAs decision to deny a request for a waiver or return of user 
fees.  
 
FDA recommends that requests for reconsideration state the applicants reasons for believing 
that FDAs decision is in error and include any additional information, including updated 
financial information that is relevant to the applicants position.  The Agency will issue a 
response upon reconsideration, setting forth the basis for the decision. 
 
All requests for reconsideration (regardless of whether the product is regulated by CDER or 
CBER) should be submitted via email to CDERCollections@fda.hhs.gov and should be 
addressed to the following:  
 
Division of User Fee Management  
Attention: Division Director 
Center for Drug Evaluation and Research 
 
Alternatively, an applicant can mail the request to FDA61 via the carrier of its choice.  For the 
most updated mailing address, visit the following FDA website: https://www.fda.gov/bsufa.  
 
B.  Appeal Request 
 
If a request is denied upon reconsideration, the applicant may choose to appeal the denial.  A 
request for an appeal should be made within 30 calendar days of the issuance of FDAs decision 
to affirm its denial of a request for a waiver or return of user fees.  The following information 
should be included in the appeal: 
 
  The original request; 
  The denial of the original request; 
  The reconsideration request; 
  The denial of the reconsideration request; and 
  A statement of the applicants reasons for believing that the prior conclusions were in 
error. 
 
No new information or new analyses should be presented in the appeal request.  If new 
information or analyses are presented in the appeal request the appeal will not be accepted and 
the matter will be referred back to the original deciding authority to consider the new 
information or analyses. 
 
61 Electronic mail is the Biosimilar User Fee staffs preferred method of receiving communication over postal mail. 
  14  Contains Nonbinding Recommendations 
 
 
All requests for appeals for either CDER or CBER products should be submitted to the Director 
of CDERs Office of Management via CDERCollections@fda.hhs.gov and a copy should be 
submitted to the CDER Formal Dispute Resolution Project Manager.  The contact information 
can be found on the CDER Formal Dispute Resolution Web page.62  Alternatively, an applicant 
can mail the request to FDA via carrier of its choice.  For the most updated mailing address, visit 
the following FDA website: https://www.fda.gov/bsufa.  
 
After FDA reviews the information submitted in the appeal request, for CDER regulated 
products the Director of CDERs Office of Management will issue a written decision on the 
applicants request; for CBER regulated products, the Director of CBER will issue a written 
decision on the applicants request. 
 
CDER Products 
If the applicants appeal is denied at one management level, the applicant can appeal the same 
matter to the next higher management level in the Center chain of command.  A new request 
should be submitted for each appeal to the next management level and should follow the process 
provided in this guidance.  If the applicant has exhausted the Centers management levels and 
remains unsatisfied with the decision, the applicant may request review of the matter by the 
Commissioner of Food and Drugs (Commissioner) under 21 CFR 10.75(c).  Requests for review 
by the Commissioner should be submitted to FDAs Ombudsman, with a copy provided to the 
Center.  Review of such matters by the Commissioner is discretionary.63   
 
CBER Products 
If the applicants appeal is denied by the Director of CBER, the applicant may request review of 
the matter by the Commissioner under 21 CFR 10.75(c).  Requests for review by the 
Commissioner should be submitted to the FDAs Ombudsman, with copies provided to the 
center that denied the appeal.  Review of such matters by the Commissioner is discretionary. 
 
 
XI.  OTHER RESOURCES 
 
The following guidance documents may be helpful: 
 
  Guidance for Industry - Submitting Separate Marketing Applications and Clinical Data 
for Purposes of Assessing User Fees64 
 
The following manuals of policies and procedures (MAPP) may be helpful: 
 
 
62 See 
https://www.fda.gov/AboutFDA/CentersOffices/OfficeofMedicalProductsandTobacco/CDER/ContactCDER/ucm44
4092.htm.  
63 See 40 FR 40682, 40693 (September 3, 1975).  
64 See 
https://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM079320.pdf. 
  15  Contains Nonbinding Recommendations 
 
  MAPP 6050.2 Effect of Failure to Pay BsUFA Fees65 
 
Additional information is also available on the FDA User Fee Programs web page.  For any 
questions, please email the BsUFA User Fee Team at CDERCollections@fda.hhs.gov or call 
301-796-7900. 
 
 
XII.  PAPERWORK REDUCTION ACT OF 1995 
 
While this guidance contains no collection of information, it does refer to previously approved 
FDA collections of information. Therefore, clearance by the Office of Management and Budget 
(OMB) under the Paperwork Reduction Act of 1995 (PRA) (44 U.S.C. 3501-3521) is not 
required for this guidance. The previously approved collections of information are subject to 
review by OMB under the PRA. The collections of information regarding BSUFA have been 
approved under OMB control number 0910-0718. The collection of information in this guidance 
including Forms FDA 3397 and 3971 have been approved under OMB control number 0910-
0297. The collection of information regarding this guidance including Form FDA 3913 has been 
approved under OMB control number 0910-0805. The collections of information associated with 
new drug applications under 21 CFR 314 or biologics license applications under 21 CFR 601 
have been approved under OMB control numbers 0910-0001 and 0910-0338, respectively.  
 
An agency may not conduct or sponsor, and a person is not required to respond to, a 
collection of information unless it displays a currently valid OMB control number.  The OMB 
control number for this information collection is 0910-0718 (expires 1/31/2025). 
 
65 See https://www.fda.gov/media/154612/download  
  16