Skip to main content
          Skip to FDA Search
          Skip to in this section menu
          Skip to footer links


U.S. flagAn official website of the United States government

					Here’s how you know
          			Dot gov**The .gov means it’s official.**Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you're on a federal government site.
							      SSL**The site is secure.** The **https://** ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely. 
			U.S. Food and Drug Administration
				
        Search
            Menu
							
						Search FDA
									
									Submit search 
		Featured
							Contact FDA
	                FDA Guidance Documents
	                Recalls, Market Withdrawals and Safety Alerts
	                Press Announcements
	                Warning Letters
	                Advisory Committees
	                En Español

					Products
            Food
							Drugs
							Medical Devices
							Radiation-Emitting Products
							Vaccines, Blood, and Biologics
							Animal and Veterinary
							Cosmetics
							Tobacco ProductsTopics
            About FDA
							Combination Products
							Regulatory Information
							Safety
							Emergency Preparedness
							International Programs
							News and Events
							Training and Continuing Education
							Inspections and Compliance
							Science and ResearchInformation For
            Consumers
	            Patients
	            Industry
	            Health Professionals
	            Federal, State and Local Officials 
 In this section:

        FDA User Fee Programs

Biosimilar User Fee Amendments

                        
                BsUFA II: Assessment of the Program for Enhanced Review Transparency and Communication in the Biosimilar User Fee Act Home
          For Industry
          FDA User Fee Programs
          Biosimilar User Fee AmendmentsFDA User Fee Programs Biosimilar User Fee Amendments
  	
        Share
    Post
    Linkedin

    Email
    Print**Latest News**

FDA has updated the address for user fees delivered by courier, such as Federal Express or UPS. Beginning October 6th, to prevent any disruption of overnight packages, please send any payment arriving via courier to:
	U.S. Bank
	Attention: Government Lockbox 979108
	3180 Rider Trail South
	Earth City, MO 63045

	If you have any questions concerning courier delivery, contact U.S. Bank at 800-495-4981.
	The FY 2024 annual invoices for BPD and/or program fee(s) were emailed to sponsors in the BPD program and applicants with program-fee eligible biosimilar products on August 15, 2023. If you do not receive your invoice(s) by August 21, 2023, please contact the BsUFA User Fee staff at CDERCollections@fda.hhs.gov. Invoices are due by October 2, 2023.
	The fiscal year (FY) 2024 BsUFA fee rates were published in the *Federal Register* (FR) on July 28, 2023. For more information regarding the FY 2024 fee rates, please see the FR notice available here.
	FDA announces the publication of the final guidance for industry entitled Assessing User Fees Under the Biosimilar User Fee Amendments of 2022*.*This guidance provides information to stakeholders regarding FDA’s implementation of the Biosimilar User Fee Amendments of 2022 (BsUFA III) and changes created by the statute to definitions, to certain user fee exceptions, and to user fee policies and procedures.
	Beginning February 13, 2023, CDER and CBER will begin accepting meeting requests for in-person, face-to-face industry meetings (with a hybrid component), starting with Type A, BPD Type 1, and Type X meeting requests.



**FY 2023 and FY 2024 User Fee Rates**

User Fee Type
			FY 2023
			FY 2024Biosimilar Biological Product Development (BPD) Fee
			Initial BPD
			$ 47,325
			$10,000Annual BPD
			$ 47,325
			$10,000Reactivation
			$ 94,650
			$20,000Application Fee
			Clinical Data Required
			$ 1,746,745
			$1,018,753Clinical Data not Required
			$ 873,373
			$509,377Program Fee
			$ 304,162
			$177,397

Background and Legislation
	The Federal Food, Drug, and Cosmetic Act (the FD&C Act), as amended by the Biosimilar User Fee Amendments of 2022 (BsUFA III), authorizes FDA to assess and collect fees for biosimilar biological products from October 2022 through September 2027. FDA dedicates these fees to expediting the process for the review of biosimilar biological product applications, including postmarket safety activities. 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.

Biosimilar User Fee Amendments of 2022
	Biosimilar Biological Product Reauthorization Performance Goals and Procedures Fiscal Years 2023 through 2027
	Biosimilar User Fee Amendments of 2017 (Title IV of the Food and Drug Administration Reauthorization Act)
	Biosimilar Biological Product Reauthorization Performance Goals and Procedures Fiscal Years 2018 through 2022
	Biosimilar User Fee Act of 2012 (Title IV of the Food and Drug Administration Safety and Innovation Act)
	Biosimilar Authorization Performance Goals and Procedures Fiscal Years 2013 through 2017

Federal Register Documents and Guidances
	Federal Register Documents

Biosimilar User Fee Rates for Fiscal Year 2024
	Agency Information Collection Activities; Proposed Collection; Comment Request; Biosimilars User Fee Program
	Biosimilar User Fee Rates for Fiscal Years 2013-PresentGuidances

Guidance Documents and Mapps

Biosimilar Biological Product Development (BPD) Fees
	**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 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.

**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?**
FDA issues invoices for the annual BPD fee for a product for the coming fiscal year in August of each year using the fee schedule for the coming fiscal year. The annual BPD fee 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;
	The sponsor has submitted a marketing application for the product that was accepted for filing; or
	The sponsor has been administratively removed from the BPD program for the product.**What is a reactivation fee?**
A sponsor that has discontinued participation in the BPD program 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 and still owed and a reactivation fee. A sponsor may resume participation in the BPD program for a product in one of two ways:

The sponsor requests a 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 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, 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, the sponsor 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?**
If a sponsor submits a biosimilar biological product application before October 1 of the fiscal year and the application is subsequently accepted for filing, the sponsor may request a refund of the annual BPD fee paid by the sponsor 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.
FDA shall not refund the initial BPD fee or reactivation fee.

Application Fees
	**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 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

Program Fees
	**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 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.

Payment Information and Cover Sheet
	**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 63197-9000Note: 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
	3180 Rider Trail South
	Earth City, MO 63045**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.

Waivers and Refunds
	**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 subsequently accepted for filing, the person may request a refund of the annual BPD fee paid by the person 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.

**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 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 should I request a small business waiver and refund?**
An applicant should submit Form FDA 3971 (Small Business Waiver and Refund Request) to CDERCollections@fda.hhs.gov at least four months prior to the submission of the application 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. 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 CDERCollections@fda.hhs.gov.

Reauthorization Activities
	BsUFA III: Fiscal Years 2023-2027
	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

Related Information
	Update on In-Person Face-to-Face Formal Meetings with FDA
	BsUFA Five-Year Financial Plans
	Therapeutic Biosimilar Biological Products List (PDF - 280 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

Contact Us
	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:

Center
			Contact
			Phone
			EmailCDER
			Biosimilar User Fee Staff
			301-796-7900
			CDERCollections@fda.hhs.govCBER
			Carla Vincent
			240-402-8177
			Carla.Vincent@fda.hhs.govIn 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.

                                                                                  Content current as of:
      10/03/2023Biosimilar User Fee Amendments                
                          

                        BsUFA II: Assessment of the Program for Enhanced Review Transparency and Communication in the Biosimilar User Fee Act
 
 Footer Links
    FDA Archive
          About FDA
          Accessibility
      Visitor Information
          Website Policies / Privacy
          No FEAR Act
          Vulnerability Disclosure Policy
      FOIA
          HHS.gov
          USA.gov
    Contact FDA
      Follow FDA on Facebook
      Follow FDA on X
      Follow FDA on Instagram
      Follow FDA on LinkedIn
      View FDA videos on YouTube
      Subscribe to FDA RSS feeds
    FDA Homepage
    Contact Number
      1-888-INFO-FDA (1-888-463-6332) Back toTop