Senator Mike Lee reintroduced his Biosimilars Red Tape Elimination Bill into the US Senate, which – if implemented, will prohibit the FDA from requiring biosimilars to undergo switching studies to obtain ‘interchangeable’ designation. Unlike small-molecule drugs, biosimilars cannot be substituted at the pharmacy level without this interchangeability designation. Sen. Lee’s bill would deem biosimilars as interchangeable with their branded equivalent upon their approval by the FDA.
Sen. Lee previously introduced the bill on 17 November 2022.