FDA wants to extend biosimilar reviews

FDA is proposing to add a 60-day period between filing of a biosimilar marketing application and the start of its review, according to notes from negotiations over reauthorization of the Biosimilar User Fee Act (BsUFA). The added review time would match changes to NDA and original BLA reviews that were instituted as part of PDUFA V.

FDA is also requesting a lower threshold above which it can spend user fees to review biosimilars. To ensure that user fees supplement rather than replace appropriated funds, the current agreement permits FDA to spend user fees on biosimilar reviews only after the agency has spent $20 million in non-user fee funds in a given year. ...