Federal Register Documents

• Biosimilar User Fee Rates for Fiscal Year 2022 
• Agency Information Collection Activities; Proposed Collection; Comment Request; Biosimilars User Fee Program 
• Reauthorization of the Biosimilar User Fee Act; Public Meeting; Request for Comments 
• Establishment of Biosimilar User Fee Rates for Fiscal Years 2013-Present 

Guidances

• Assessing User Fees Under the Biosimilar User Fee Amendments of 2017
• Labeling for Biosimilar Products (PDF - 143KB)
• Implementation of the “Deemed to be a License” Provision of the Biologics Price Competition and Innovation Act of 2009 (PDF - 139KB)

   Search "Biosimilar" on the Guidances for Drugs webpage for more Biosimilar guidances.

What are the BPD Fees?
BPD fees are assessed for products in FDA’s BPD program. BPD fees include the initial BPD fee, the annual BPD fee, and the reactivation fee. 

What is an 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. A sponsor can enter the BPD program through one of two ways:

• The sponsor submits to FDA a meeting request for a BPD meeting for a product; or
• The sponsor submits 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.

There is no fee for a biosimilar initial advisory meeting.

When is the initial BPD fee due?
The initial BPD fee is due within 5 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.

What is an annual BPD fee?
Beginning in the next fiscal year after a sponsor has paid the initial BPD fee, the sponsor must pay an annual fee for the product in each fiscal year.

When is the annual BPD fee due?
The annual BPD fee for a product is 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, unless the sponsor has discontinued participation in the BPD program for the product or has submitted a biosimilar biological product application for the product that was accepted for filing.

What is a reactivation fee?
A sponsor that has discontinued participation in the BPD program for a product and wants to resume participation in the BPD program for the product must pay a reactivation fee. A sponsor may resume participation in the BPD program for a product in one of two ways:

• The sponsor requests a biosimilar BPD meeting for the product; or
• The sponsor submits a clinical protocol for an IND describing an investigation that FDA determines is intended to support a biosimilar biological product application for the product.

When is the reactivation fee due?
The reactivation fee is due within 5 calendar days after FDA grants a 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.

The reactivation fee for a fiscal year will be equal to twice the amount of the annual BPD fee established for that fiscal year. Beginning in the next fiscal year after a sponsor has paid the reactivation fee, the sponsor must pay an annual BPD fee.

How do I pay BPD fees?
Visit our Payment Information and Cover Sheet tab for information on how to pay BPD fees.

How can I discontinue participation in the BPD program?
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:

• 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. The sponsor should send a courtesy copy to [email protected] and include the following information in the letter:
  • Sponsor’s contact information including name, address, email, and telephone number
  • Identify the request at the top of the cover letter as “Request to Discontinue Participation in the BPD Program”
  • Name of product
  • Pre-IND number
• 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
  • In addition to withdrawing the IND, a sponsor wishing to discontinue participation should also submit to FDA a written request to discontinue participation in the BPD program, as described above, with a courtesy copy to [email protected].

Where do I send my request to discontinue participation in the BPD program?
Requests to discontinue participation in the BPD program can be submitted to the FDA Electronic Submissions Gateway or mailed to:

Food and Drug Administration
Center for Drug Evaluation and Research
Central Document Room
5901-B Ammendale Road
Beltsville, MD 20705-1266

Is there a deadline to submit a request to discontinue from the BPD program?
FDA must receive the request by August 1 of the preceding fiscal year to avoid assessment of the annual BPD fee. 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.

Is there a refund of BPD fees paid?
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.

What are application fees?
FDA assesses a user fee for each biosimilar biological product application 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.
• 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.

Is there a reduction of application fees?
There is no reduction of an application fee. The application fee is due when the application is submitted.

How do I pay a fee?
Visit our Payment Information and Cover Sheet tab information on how to pay an application fee.

Are there any exceptions to the fee requirements?
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 (without a waiver),

the submission of a biosimilar biological product application for the same product by the same person (or the person’s licensee, assignee, or successor) does not require an application fee.

Are there exceptions to the biosimilar biological product application?
Yes, such term does not include

• a supplement to such an application
• an application filed under section 351(k) of the PHS Act that cites as a reference product a bovine blood product for topical application licensed before September 1, 1992, or a large volume parenteral drug product approved before such date
• an application filed under section 351(k) of the PHS Act with respect to
  • whole blood or blood component for transfusion
  • an allergenic extract product
  • an in vitro diagnostic biological product
  • a biological product for further manufacturing use only
• an application for licensure under 351(k) of the PHS Act that is submitted by a State or Federal Government entity for a product that is not distributed commercially

What are biosimilar biological product program fees?
The biosimilar biological product program fee is assessed annually for each eligible biosimilar biological product. Program fees are assessed to each person who is named as the applicant in a biosimilar biological product application for each biosimilar biological product identified in an approved biosimilar biological product application as of October 1 of such fiscal year, where the product does not appear on a list of discontinued biosimilar biological products (as of October 1 of such fiscal year).

What is a biosimilar biological product?
A biosimilar biological product is a specific strength of a biological product in final dosage form for which a biosimilar biological product application has been approved (section 744G(3) of the FD&C Act).

Are there any exceptions to the program fee requirements?
An annual program fee for a fiscal year is not assessed

• if the products are identified in a biosimilar biological product application approved after October 1 of such fiscal year; and
• the biosimilar biological product does not appear on a list of discontinued biosimilar biological products as of October 1 of such fiscal year

Are there limits to the program fee?
Applicants may not be assessed more than five program fees for biosimilar biological products identified in each approved application for each fiscal year.

When are the program fees due?
The program fees are 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 fees for such year.

How do I pay a fee?
Visit our Payment Information and Cover Sheet tab for information on how to pay program fees.

How do I pay initial BPD fees, reactivation fees, and application fees?
First complete a Biosimilar User Fee Cover Sheet to generate a user fee identification (ID) number. Further instructions are provided when you access the link.

Include the Biosimilar User Fee Cover Sheet with your payment and with your submission to FDA. Payment must be made in U.S. currency by electronic check (ACH), wire transfer, check, bank draft, or U.S. postal money order.

By electronic check (ACH)
FDA has partnered with the U.S. Department of the Treasury to utilize Pay.gov, a Web-based payment application, for online electronic payment.

The Pay.gov feature is available on the FDA Web site after completing the Biosimilar User Fee Cover Sheet, and generating the user fee ID number.

By wire transfer
Please reference your unique user fee ID number, generated after submitting the Biosimilar User Fee Cover Sheet, when completing your transfer.

The originating financial institution may assess an additional fee for wire transfer payments. Please ask your financial institution about this fee and include it with your payment to ensure that your fee is fully paid.

• The account information is as follows:
  
  New York Federal Reserve Bank
  U.S. Department of Treasury
  TREAS NYC
  33 Liberty Street
  New York, NY 10045
  FDA Deposit Acct. No.: 75060099
  Routing No.: 021030004
  SWIFT: FRNYUS33
  Beneficiary: FDA, 8455 Colesville Road, COLE-14-14253, Silver Spring, MD 20993-0002

By check, bank draft, or postal money order
Please include the user fee ID number, generated after submitting the Biosimilar User Fee Cover Sheet on your check, bank draft, or postal money order, and make payable to the order of the Food and Drug Administration.

Include a copy of the Biosimilar User Fee Cover Sheet with your payment. Payment must be made in U.S. currency by electronic check (ACH), wire transfer, check, bank draft, or U.S. postal money order.

• Mail payment to:
  Food and Drug Administration
  P.O. Box 979108
  St. Louis, MO 63197-9000
  
  Note: In no case should payment be included with the review submission
• If checks are to be sent by a courier requiring a street address, deliver the checks to the address below. Please note: This address is for courier delivery only.
  
  U.S. Bank
  Attention: Government Lockbox 979108
  1005 Convention Plaza
  St. Louis, MO 63101.

How do I pay the annual BPD fees and program fees?
FDA will issue invoices for annual BPD fees and program fees. Invoices will include payment instructions.

Is it possible to receive a refund of the annual BPD fee?
If a person submits a biosimilar biological product application before October 1 of the fiscal year and the application is accepted for filing on or after October 1 of that fiscal year, the applicant may request a refund of the annual BPD fee paid by the applicant for such fiscal year. FDA must receive a written request for a refund not later than 180 calendar days after the application is accepted for filing. Submit Form FDA 3913 (User Fee Payment Refund Request) to [email protected] within 180 calendar days from the date the application was accepted for filing.

Is it possible to receive a refund of the application fee?
If an application is refused for filing or is withdrawn without a waiver before filing, FDA will refund 75% of the application fee paid. A written refund request is not required.

An application that was withdrawn before filing or refused for filing will be subject to the full application fee when resubmitted, unless a waiver applies.

Are there any waivers for application fees?
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 application 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.

How do I request a small business waiver and refund?
An applicant should submit Form FDA 3971 (Small Business Waiver and Refund Request) to [email protected] to see if they qualify for a small business waiver.

Do small business waivers expire?
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 change rapidly. 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.

Where should I send a refund or waiver request?
Please submit a refund or waiver request by electronic mail to the Biosimilar User Fee staff at [email protected].

• BsUFA III: Fiscal Years 2023-2027
• BsUFA II Five-Year Financial Plan (PDF - 449 KB)
• BsUFA Meetings
• BsUFA I Authorization
• Financial Transparency and Efficiency
• Resource Capacity Planning and Modernized Time Reporting Implementation Plan
• Food and Drug Administration Reauthorization Act (FDARA) of 2017 Hiring Data

• BsUFA Five-Year Financial Plans 
• Therapeutic Biosimilar Biological Products List (PDF - 237 KB)
• Purple Book: Lists of Licensed Biological Products with Reference Product Exclusivity and Biosimilarity or Interchangeability Evaluations
• Review of Biosimilar Biologic Product Applications: Study of Workload Volume and Full Costs- Interim and Final Report 
• BsUFA Financial Reports
• BsUFA Performance Reports
• Fact Sheet: New "Biosimilars" User Fees Will Enhance Americans' Access to Alternatives to Biologic Drugs
• BsUFA User Fee Rates Archive
• BsUFA I Fee Information

 For technical assistance with accessing and completing the Biosimilar User Fee Coversheet, email the User Fee Help Desk at [email protected] or call 301-796-7200.

For questions about BsUFA fee requirements, waivers, or refunds:

Center	Contact	Phone	Email
CDER	Biosimilar User Fee Staff	301-796-7900	[email protected]
CBER	Carla Vincent	240-402-8177	[email protected]

In the rare instance where you are unable to submit an electronic request, you may mail your request, via the carrier of your choice, to FDA, Division of User Fee Management, 10001 New Hampshire Ave, Silver Spring, MD 20993.