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Biosimilar User Fee Act (BsUFA)

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  • In preparation for FDA’s annual FY 2019 BsUFA invoices, the Notification of Annual BsUFA Fees correspondence was emailed on Friday, June 15, 2018. Please submit your response by Friday, June 29, 2018. If you have any questions, please contact us at CDERCollections@fda.hhs.gov.

FY18 BsUFA Fees

BPDInitial$ 227,213
Annual$ 227,213
Reactivation$ 454,426
Applicationw/Clinical Data $ 1,746,745
w/o Clinical Data $ 873,373
Program$ 304,162

The Federal Food, Drug, and Cosmetic Act (the FD&C Act), as amended by the Biosimilar User Fee Amendments of 2017 (BsUFA II), authorizes FDA to assess and collect fees for biosimilar biological products from October 2017 through September 2022. FDA dedicates these fees to expediting the review process for biosimilar biological products. Biosimilar biological products represent an important public health benefit, with the potential to offer life-saving or life-altering benefits at reduced cost to the patient. BsUFA facilitates the development of safe and effective biosimilar products for the American public.

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 CDERCollections@fda.hhs.gov 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 CDERCollections@fda.hhs.gov.

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 CDERCollections@fda.hhs.gov 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.

Is it possible to transfer a payment I’ve already made from one application to another application?
If an applicant wishes to transfer a payment from one application to another, they may submit Form FDA 3914 (User Fee Payment Transfer Request) to CDERCollections@fda.hhs.gov to request a transfer of user fees paid to the FDA.

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?
To see if an applicant qualifies for a small business wavier of the biosimilar biological product application fee, they can submit Form FDA 3971 (Small Business Waiver and Refund Request) to CDERCollections@fda.hhs.gov.

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?
The preferred method to submit a refund or waiver request is via email to CDERCollections@fda.hhs.gov.

If you wish to send the request via mail, you can send it to:

For US Mail:
Biosimilar User Fee Staff
Food and Drug Administration
10001 New Hampshire Avenue, Room 2185
Silver Spring, MD 20993-0002

For Courier Delivery:
Biosimilar User Fee Staff
Food and Drug Administration
10001 New Hampshire Avenue, Room 2185
Silver Spring, MD 20903

For technical assistance with accessing and completing the Biosimilar User Fee Coversheet, email the User Fee Help Desk at userfees@fda.gov or call 301-796-7200.

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

CenterContactPhoneEmail
CDERBiosimilar User Fee Staff301-796-7900CDERCollections@fda.hhs.gov
CBERCarla Vincent240-402-8177Carla.Vincent@fda.hhs.gov

 

Page Last Updated: 06/15/2018
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