Biosimilars and interchangeable biologics are going to be a big business, of course, and so the FDA is now devising a user fee program to fund its own review efforts. Toward that end, the agency is posting a notice on the Federal Register today in order to seek comments that can be submitted to Congress by January.
However, the program envisioned by the FDA may not exactly mirror PDUFA, the user fee program for prescription meds, for one simple reason - the biosimilar market is just getting started, so biosimilar user fees will have to "include different elements to ensure an equitable program that generates adequate revenue." Meanwhile, the agency offers these principles for creating a program.
One, biosimilar and interchangeable biologics represent a critical public health benefit to patients, with the potential to offer life-saving or life-altering benefits at reduced costs to the patient. FDA needs sufficient review capacity to prevent unnecessary delays in the development and approval of these products;
Two, at least for the initial 5-year authorization of the user fee program, the user fees should remain comparable to user fees under PDUFA; Three, the user fee program should provide funding to support activities that occur early in the biosimilar and interchangeable product development cycle; and four, the user fee program should ensure adequate resources for the review of applications, so that critical resources for review are not redirected from innovator drug review to biosimilar products.”
That said, how much money is the FDA talking about? The agency proposes four different types of fees – two in the pre-market approval phase and two in the marketed phase. On proposed pre-market approval user fee would cost $150,000 to “support the ongoing scientific, technical, and other regulatory activities associated with biosimilar development, including milestone meetings and the application data reviews required to provide advice for the next steps in development.”
The other 'Marketing Application Fee' would be paid for each submitted marketing application, and the amount would be equal to a marketing application fee under PDUFA, after subtracting the sum of all of the previously paid annual biosimilar product development fees associated with the biosimilar product that is the subject of the application, according to the FDA notice. As for the two proposed marketed phase user fees, the agency proposes the annual establishment and product fees that would be set equal to the PDUFA fees established annually by the agency.
For those wishing to comment, the agency will ask you to consider a few questions. One is which factors should the FDA consider in determining appropriate performance goals for applications that are filed earlier than two years prior to the date on which an application would be eligible for approval (for example, should this be 12 years after the date of first licensing of the reference product)?
Another question is how should performance goals take into account readiness for inspection? And what other factors relating to the unique characteristics of the approval pathway should the Agency consider when setting performance goals for applications? (read the entire notice here).
pic thx to AMagill on flickr