It seems that the FDA has decided that biosimilar sponsors will not be required to meet with the agency at specific times or for specific reasons during the IND phase of development, allowing them more flexibility early in the process.
Product development fees would be collected when a biosimilar sponsor files an IND. It is expected to be about 10% of the cost to file for a marketing application review and be charged annually as long as the product remains in active development stages.
FDA wants the earlier infusion of funding to support agency activities during the biosimilar IND stage, which are expected to be more extensive than those for other applications. The agency agreed to discount all product development fee payments from the marketing application fee once it is filed
FDA and the brand and generic industry representatives also may have ended their dispute over whether the biosimilar user fee program should be independent of the other user fee programs.
At an August 8th meeting the agency circulated draft statutory language authorizing creation of the program independent of other user fees. The minutes did not indicate opposition by GPhA on any portions of the proposal. There also was no mention in the minutes of further discussion of the appropriations trigger.
The agency agreed to write a draft commitment letter for discussion at another negotiating session, another indication both sides have moved beyond the issue.
The biosimilar user fee program is expected to be included in an omnibus bill that also will include the Medical Device User Fee and Modernization Act and PDUFA reauthorizations, as well as the new generic drug user fee program.