The biosimilar biological product development (BPD) fee has been set at $195,880 (10% of the full application fee). This is the amount due when a sponsor submits an investigational new drug (IND) application for a biosimilar (or within 5 days of FDA granting a BDP meeting request – whichever occurs first).
When a sponsor is ready to submit a fully-developed biosimilar marketing application, the application fee for FY 2013 is $1,958,800 ($979,400 if the application does not include clinical data).
Notably, President Obama’s budget for FY 2013 projected approximately $20 million to be collected by the federal government in biosimilar user fees. Based on the just-announced user-fee rates, therefore, a maximum of 10 biosimilar marketing applications have been anticipated, and probably somewhat fewer depending on whether (and how many) INDs are anticipated. However, even if we see half that many applications in FY 2013, it will still be enough to trigger a host of novel issues, including the sharing of each application with the corresponding pioneer and the initiation of the biosimilar patent exchange procedures.
FDA published details of the user fees in an August 1, 2012 federal register notice.