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New biosimilars bill aims to remove interchangeable requirement for pharmacy substitution

Nov 17, 2022

Senator Mike Lee (R-UT) introduced the 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.

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