H.R.2430 – FDA Reauthorization Act of 2017, a bill reauthorizing all of the U.S. Food and Drug Administration (“FDA”) user fee programs, including reauthorization of the Biosimilar User Fee Act (“BsUFA II”), was passed in the House of Representatives on July 12, 2017, with bipartisan support by voice vote. The House bill comes as the current legislative authority is set to expire at the end of September 2017.
As discussed previously here, BsUFA II creates important changes for biosimilar applicants, including new user fees and application timelines. In particular, the bill would increase user fees from $508 million to $1.3 billion in 2018 and extend the application review timeline by two months, while empowering the FDA to collect $9 billion in user fees between 2018 and 2022. More complete details on the changes to the legislative authority can be found in our previous post located here.
The Senate’s version of the bill was passed by the Committee on Health, Education, Labor & Pensions (“HELP Committee”) on May 11, 2017, where it continues to await a floor debate and vote.