Wooden Blocks with the text: Fees

Biosimilar User Fees Announced for FY 2019

The Federal Register notice published today (here) announces the FY 2019 biosimilar user fees.

The initial Biologic Product Development (BPD) fee is due when the sponsor submits an Investigational New Drug (IND) application to the Agency or within five days after the FDA grants the first BPD meeting.  The annual BPD fee is assessed the following FY and each year until the sponsor submits a marketing application or until the sponsor notifies the FDA that it is no longer participating in the program; the reactivation fee must be paid for a product that was discontinued from the program and then brought back into the program.

Biosimilar User Fees for FY 2017

The fees for applications with and without clinical information are self-explanatory, and for approved biosimilar applications, there is a program fee that is assessed for up to five different products in a single application.

The biosimilar program permits a small business waiver of the first biosimilar application for a qualified small business.