In the Press
May 31, 2022

505(b)(2)-Like Pathway for Biologics May Gain Renewed Interest with Senate User Fee Bill Pending (Pink Sheet)


Draft legislative text would allow some biologics and biosimilars to rely on published literature or other information and avoid some clinical studies, but the wide FDA discretion also included could raise more questions. A legislative proposal intended to streamline development of so-called biobetters could be looking for a home in the US Food and Drug Administration’s user fee reauthorization package moving through Congress. Brian Burgess, an Appellate Litigation partner at Goodwin, told the Pink Sheet that the proposal would restore an approval route for some follow-on products now regulated as biologics after the March 2020 transition of some NDAs to BLAs. Read the Pink Sheet article here.