In today's Federal Register, the FDA proposed a user-fee program to support the review of biosimilars and interchangeable biological products applications. In its initial inception, it will somewhat mirror the Prescription Drug User Fee Act (PDUFA) fee program but will not exactly match it.
The FDA says that is wants to emphasize help in the early stages of the biosimilar development cycle and do so in a way that will not drain resources from the review of innovator products. Under the proposal, for an application in the premarket phase, there would be a biosimilar product development fee paid on submission of the application and annually thereafter -- on the order of $150,000. A marketing application fee would be equal to the PDUFA original new drug fee less the sum of payments from the development fees above.
Once the product reached market, there would be annual establishment and product fees equal to the respective PDUFA fees. This total fee structure would be exepcted to stay in place for the first five years of the program -- and then may be adjusted as necessary. The FDA expects to be issuing guidelines for the entire biosimilars licensing process later this year. At least with the fee proposal, we're once step closer to activating a biosimilars regulatory pathway. See Fierce Biotech and Pharmalot.
Posted by Bruce Lehr May 10th 2011.