BsUFA Fees, Exceptions, Waivers, and Refunds
The Federal Food, Drug, and Cosmetic Act (the FD&C Act), as amended by the Biosimilar User Fee Act of 2012 (BsUFA), authorizes FDA to assess and collect fees for activities in connection with biosimilar biological product development, applications for approval of biosimilar biological products, establishments where such products are manufactured in final dosage form, and biosimilar biological products.
Biosimilar biological product development (BPD) fees
- Initial BPD fee
- Annual BPD fee
- Reactivation Fee
- Discontinue participation in the BPD program
- BPD Fee Exceptions
- BPD Fee Waivers
- BPD Fee Refunds
Application and supplement fees
- Application and supplement fee exceptions
- Application fee small business waiver
- Application and supplement fee refunds
- Process to request waiver or refund
Biosimilar biological product development (BPD) fees
BsUFA includes BPD fees for products in FDA’s Biosimilar Biological Product Development (BPD) Program. BPD fees consist of the initial BPD fee, the annual BPD fee, and the reactivation fee. The BPD fee is an annual per-product fee, not a per-meeting or per-review activity fee.
When do I pay the initial BPD fee?
- Under section 744H(a)(1)(A)(iv), the initial BPD fee is due within five calendar days after FDA grants the first BPD meeting for the product, or upon submission of an investigational new drug application (IND) describing an investigation that FDA determines is intended to support a biosimilar biological product application for the product, whichever occurs first.
- INDs submitted prior to October 1st, 2012 – Under section 744H(a)(1)(A)(v), for a sponsor that has submitted an IND prior to October 1st, 2012, if FDA determines that the IND describes an investigation that is intended to support a biosimilar biological product application, FDA expects the initial BPD fee to be paid by December 1st, 2012 (unless the IND is withdrawn before the fee due date), or within five days after FDA grants a BPD meeting for the product, whichever occurs first.
- There is no fee for a biosimilar initial advisory meeting.
Do I pay an initial BPD fee for each BPD meeting and IND submission for a product?
- The initial BPD fee is a one-time per-product fee, not a per-meeting or per-review activity fee.
- A sponsor pays only one initial BPD fee per product.
Do I have another BPD fee obligation after I pay the initial BPD fee for a product?
- Under section 744H(a)(1)(B), beginning in the next fiscal year1 after a sponsor has paid the initial BPD fee for a product, the sponsor must pay an annual BPD fee for the product in each fiscal year unless the sponsor discontinues participation in the BPD program for the product or submits a biosimilar biological product application for the product that is accepted for filing.
How much is the initial BPD fee?
- Under section 744H(b)(1)(A), the initial BPD fee rate for a fiscal year equals 10% of the fee rate established under the Prescription Drug User Fee Act (PDUFA) for a human drug application requiring clinical data for that fiscal year.
How do I pay the initial BPD fee?
- Complete a Biosimilar User Fee Cover Sheet and pay by electronic check, wire transfer, check, money order, bank draft, or U.S. postal money order.
What happens if I do not pay the initial BPD fee?
Under section 744(a)(1)(E), if the initial BPD fee for a product is not paid by the due date:
- FDA will cancel the scheduled BPD meeting for the product
- Except in extraordinary circumstances, if you have an existing IND for the product, FDA will place the IND on financial hold
- Except in extraordinary circumstances, if you submit an IND for the product that FDA determines is intended to support a biosimilar biological product application, FDA will not consider the IND for the product to have been “received” under section 505(i)(2) of the FD&C Act.
When do I pay the annual BPD fee?
- Under sections 744H(a)(1)(B) and 744H(a)(1)(D), beginning in the next fiscal year after a sponsor has paid the initial BPD fee or reactivation fee for a product, the sponsor must pay an annual BPD fee for the product each fiscal year unless the sponsor discontinues participation in the BPD program for the product or submits a marketing application for the product that is accepted for filing.
- Under section 744H(a)(1)(B)(ii), the annual BPD fee for a product is due the first business day on or after October 1st of each year.
How many annual BPD fees are assessed for a product in each fiscal year?
- A sponsor is assessed only one annual BPD fee per product per fiscal year.
How much is the annual BPD fee?
- Under section 744H(b)(1)B), the annual BPD fee rate for a fiscal year equals 10% of the fee rate established under the Prescription Drug User Fee Act (PDUFA) for a human drug application requiring clinical data for that fiscal year.
How do I pay the annual BPD fee?
- FDA issues invoices for the annual BPD fee. Invoices include payment instructions.
What happens if I do not pay the annual BPD fee?
- If the annual BPD fee for a product is not paid by the due date:
- FDA will deny any BPD meeting requests for the product, and cancel any scheduled BPD meetings for the product
- Except in extraordinary circumstances, if you have an existing IND for the product, FDA will place the IND on financial hold
- Except in extraordinary circumstances, if you submit an IND for the product that FDA determines is intended to support a biosimilar biological product application, FDA will not consider the IND for the product to have been “received” under section 505(i)(2) of the FD&C Act.
- Any biosimilar biological product application or supplement submitted by you or an affiliate will be considered incomplete and will not be accepted for filing until the outstanding fee has been paid. See section 744H(a)(1)(E).
- Under section 744H(f), if FDA does not receive payment of a fee assessed under section 744H(a) within 30 days after it is due, the fee is treated as a claim of the United States Government subject to subchapter II, chapter 37 of title 31, United States Code.
When do I pay the reactivation fee?
- Under section 744H(a)(1)(D)(i), a sponsor that has discontinued participation in the BPD program for a product, and wants to again engage with FDA on development of the product as a biosimilar biological product, must pay a reactivation fee in order to resume participation in the BPD program for that product.
- The reactivation fee is due within five calendar days after FDA grants a BPD meeting for the product or upon submission of an IND that FDA determines is intended to support a biosimilar biological product application for the product, whichever occurs first.
Do I pay a reactivation fee for each BPD meeting and IND submission for a product?
- The reactivation fee is an annual per-product fee, not a per-meeting or per-review activity fee.
- A sponsor pays only one reactivation fee per product per fiscal year.
Do I have another BPD fee obligation after I pay the reactivation fee for a product?
- Under section 744H(a)(1)(D)(ii), 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 the product each fiscal year.
How much is the reactivation fee?
- Under section 744H(b)(1)(C), the reactivation fee for a fiscal year equals 20% of the fee rate established under the Prescription Drug User Fee Act (PDUFA) for a human drug application requiring clinical data for that fiscal year.
How do I pay the reactivation fee?
- Complete a Biosimilar User Fee Cover Sheet and pay by electronic check, wire transfer, check, bank draft, or U.S. postal money order.
What happens if I do not pay the reactivation fee?
Under section 744H(a)(1)(E), if the reactivation fee for a product is not paid by the due date:
- FDA will cancel the scheduled BPD meeting for the product
- Except in extraordinary circumstances, if you submit an IND for the product that FDA determines is intended to support a biosimilar biological product application, FDA will not consider the IND for the product to have been “received” under section 505(i)(2) of the FD&C Act.
How do I discontinue participation in the BPD program?
Under section 744H(a)(1)(C), a sponsor may discontinue participation in the BPD program for a product, which discontinues the annual BPD fee obligation for the product, effective October 1st of a fiscal year, by notifying FDA on or before August 1st of the preceding fiscal year.
- No IND – If no IND for the product has been submitted, a sponsor may discontinue participation by submitting a written declaration to FDA that the sponsor has no present intention of further developing the product as a biosimilar biological product.
- Send the letter to the Center’s document room.
- Include the following information in the letter:
- Sponsor’s contact information including name, address, e-mail, and telephone number
- Identify the request at the top of the cover letter as “Biosimilar Development Discontinued Request”
- Name of product
- Pre-IND number of product
- IND – If an IND has been submitted, a sponsor may discontinue participation by withdrawing the IND for the product as specified in Part 312 of Title 21 of the Code of Federal Regulations.
Are there any exceptions for BPD fees?
- Under section 744H(a)(1)(B)(iii), a sponsor maintaining an IND for a product or requesting a BPD meeting for a product after submitting a biosimilar biological product application for the product that was accepted for filing does not pay BPD fees for that product.
- If the IND or BPD meeting request is for one of the following types of products, BPD fees do not apply:
- Whole blood or blood component for transfusion;
- An allergenic extract product;
- An in vitro diagnostic biological product;
- A product that is not distributed commercially, provided that the meeting request is submitted by a state or federal government entity;
- A biological product for further manufacturing use only; or
- A product that cites as the reference product a bovine blood product for topical application, or a large volume parenteral product, that was approved before September 1, 1992.
Are there any waivers of BPD fees?
- No. FDA will not grant a waiver, exemption, or reduction of BPD fees. See section 744H(a)(1)(F).
Are there any refunds of BPD fees?
- No. FDA will not refund any paid BPD fees. See section 744H(a)(1)(F).
Application and supplement fees
When do I pay the application and supplement fees?
- Under section 744H(a)(2)(C), application and supplement fees are due upon submission of the application or supplement, unless waived under section 744H(a)(2)(D).
How much are the application and supplement fees?
- Section 744H(a)(2)(A) establishes the fees for applications and supplements.
Fee Category | Fee Rate |
|---|---|
Biosimilar biological product application requiring clinical data (other than comparative bioavailability studies) for approval | Set equal to the fee rate established for that fiscal year under PDUFA for a human drug application requiring clinical data (other than comparative bioavailability studies) for approval * |
Biosimilar biological product application not requiring clinical data (other than comparative bioavailability studies) for approval | Set equal to half the fee rate established for that fiscal year for a biosimilar biological product application requiring clinical data (other than comparative bioavailability studies) for approval * |
Biosimilar biological product supplement requiring clinical data (other than comparative bioavailability studies) for approval | Set equal to half the fee rate established for that fiscal year for a biosimilar biological product application requiring clinical data (other than comparative bioavailability studies) for approval |
*Under section 744H(a)(2)(B), if a sponsor that submits a biosimilar biological product application has previously paid initial BPD, annual BPD, or reactivation fees for the product that is the subject of the application, the fee for the application is reduced by the cumulative amount of these previously paid fees.
How do I pay the application and supplement fees?
- Complete a Biosimilar User Fee Cover Sheet and pay by electronic check, wire transfer, check, bank draft, or U.S. postal money order.
What happens if I do not pay the application and supplement fees?
Under section 744H(d), if the application or supplement fee is not paid by the due date:
- The biosimilar biological product application or supplement will be considered incomplete and will not be accepted for filing.
Are there any exceptions for application and supplement fees?
- Under section 744H(a)(2)(D), the application or supplement is not subject to a fee if the person previously paid the application or supplement fee for the same product for the same indications, and the application or supplement was accepted for filing and was not approved or was withdrawn (without a waiver).
- There is no fee for a supplement not requiring clinical data (other than comparative bioavailability studies) for approval.
- If the application or supplement is for one of the following types of products, BPD fees do not apply:
- Whole blood or blood component for transfusion;
- An allergenic extract product;
- An in vitro diagnostic biological product;
- A product that is not distributed commercially, provided that the meeting request is submitted by a state or federal government entity;
- A biological product for further manufacturing use only; or
- A product that cites as the reference product a bovine blood product for topical application, or a large volume parenteral product, that was approved before September 1, 1992.
Are there any waivers of application and supplement fees?
- Under section 744H(c), FDA waives the application fee for the FIRST biosimilar biological product application submitted by a small business or its affiliate.
- The small business or affiliate must meet all of the following criteria:
- Fewer than 500 employees, including employees of affiliates.
- Does not have a drug product that has been approved under a PDUFA human drug application or a biosimilar biological product application, and introduced or delivered for introduction into interstate commerce.
- The small business or affiliate must meet all of the following criteria:
Are there any refunds of application and supplement fees?
- Under section 744H(a)(2)(E), FDA refunds 75% of the application or supplement fee paid for any application or supplement refused for filing or withdrawn without a waiver before filing.
What is the process to request a waiver or refund?
- Under section 744H(g), to qualify for consideration for a small business waiver, or for a refund of any fee collected in accordance with section 744H(a)(2)(A), submit a written request to FDA for such waiver or refund not later than 180 calendar days after such fee is due.
- Include the following information in the request:
- Company name and address
- Name and telephone number of the contact person for the fee waiver
- Application submission tracking number
- Date of the submission
- Send the waiver or refund request by e-mail or mail to:
Attention: Biosimilar User Fee Staff
Food and Drug Administration
10001 New Hampshire Avenue, Room 2185
Silver Spring, MD 20993
Email: [email protected]
Phone: 301-796-7900
Establishment Fee
When do I pay the establishment fee?
- Under section 744H(a)(3)(A), each applicant named in a biosimilar biological product application is assessed an annual fee for each biosimilar biological product establishment listed in the approved biosimilar biological product application as an establishment that manufactures the biosimilar biological product in final dosage form.
- Under section 744H(a)(3)(B), each biosimilar biological product that is assessed a biosimilar biological product fee is assessed a biosimilar biological product establishment fee in each fiscal year unless the establishment listed in the application does not engage in the manufacture the product during the fiscal year.
- Under section 744H(a)(3)(C), the establishment fee is due the first business day on or after October 1st of each year.
How many establishment fees are assessed for an establishment in each fiscal year?
- Under section 744H(a)(3)(D)(i), each biosimilar biological product establishment is assessed only one biosimilar biological product establishment fee per fiscal year, notwithstanding the number of biosimilar biological products manufactured at the establishment.
- Under section 744H(a)(3)(D)(ii), if more than one applicant lists the same establishment in a biosimilar biological product application, the biosimilar biological product establishment fee for the fiscal year is divided equally among the applicants whose biosimilar biological products are manufactured by the establishment during the fiscal year.
- The establishment fee is divided equally among the number of applicants manufacturing biosimilar biological products at the establishment, not the number of biosimilar biological products manufactured at the establishment.
How much is the establishment fee?
- Under section 744H(b)(1)(E), the annual biosimilar biological product establishment fee is set equal to the fee for a prescription drug establishment under PDUFA for that fiscal year.
How do I pay the establishment fee?
- FDA issues invoices for the annual establishment fee. Invoices include payment instructions.
What happens if I do not pay the establishment fee?
If the establishment fee is not paid by the due date:
- Under section 744H(d), any biosimilar biological product application or supplement submitted by the person will be considered incomplete and will not be accepted for filing.
- Under section 744H(f), if FDA does not receive payment of a fee assessed under section 744H(a) within 30 days after it is due, the fee is treated as a claim of the United States Government subject to subchapter II, chapter 37 of title 31, United States Code.
Are there any exceptions for establishment fees?
- Under section 744H(a)(3)(B), if the establishment listed in the biosimilar biological product application does not engage in the manufacture of the biosimilar biological product during the fiscal year, the applicant is not assessed an establishment fee.
- Under section 744H(a)(3)(E), when the manufacture of a biosimilar biological product is started during the year, after the establishment fee has already been assessed, and the establishment did not manufacture the biosimilar biological product in the previous fiscal year, the applicant is not assessed an establishment fee for that fiscal year.
- An applicant is not assessed a biosimilar biological product establishment fee for:
- Whole blood or blood component for transfusion;
- An allergenic extract product;
- An in vitro diagnostic biological product;
- A product that is not distributed commercially, provided that the meeting request is submitted by a state or federal government entity;
- A biological product for further manufacturing use only; or
- A product that cites as the reference product a bovine blood product for topical application, or a large volume parenteral product, that was approved before September 1, 1992.
Product Fee
When do I pay the product fee?
- Under section 744H(a)(4)(A), product fees are assessed annually for eligible products. Product fees are assessed on each person who is named as the applicant in an approved biosimilar biological product application.
- Under section 744H(a)(4)(B), the product fee is due the first business day on or after October 1st of each year.
How many product fees are assessed for a product in each fiscal year?
- Under section 744H(a)(4)(C), each product is assessed only one biosimilar biological product fee per fiscal year.
How much is the product fee?
- Under section 744H(b)(1)(F), the annual biosimilar biological product fee is set equal to the fee for a prescription drug product under PDUFA for any fiscal year.
How do I pay the product fee?
- FDA issues invoices for the annual biosimilar biological product fee. Invoices include payment instructions.
What happens if I do not pay the product fee?
If the biosimilar biological product fee is not paid by the due date:
- Under section 744H(d), any biosimilar biological product application or supplement submitted by the person will be considered incomplete and will not be accepted for filing.
- Under section 744H(f), if FDA does not receive payment of a fee assessed under section 744H(a) within 30 days after it is due, the fee is treated as a claim of the United States Government subject to subchapter II, chapter 37 of title 31, United States Code.
Are there any exceptions for product fees?
Biosimilar biological product fees are not assessed for the following types of products:
- Whole blood or blood component for transfusion;
- An allergenic extract product;
- An in vitro diagnostic biological product;
- A product that is not distributed commercially, provided that the application under which the application was approved was submitted by a state or federal government entity;
- A biological product for further manufacturing use only; or
- A product that cites as the reference product a bovine blood product for topical application, or a large volume parenteral product, that was approved before September 1, 1992.
What should I do if I receive a full or partial refund that I was not expecting?
- If you do not know why you received a refund, contact the User Fee Helpdesk at [email protected] or 301-796-7200.
Footnote
1FDA’s fiscal year is the 12 month period from October 1st through September 30th. For example, fiscal year 2013 is October 1st, 2012 through September 30th, 2013.