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.