As Stelara biosimilars wait in the wings, proposed legislation in the US could ease the path to commercialization. The Draft Red Tape Elimination Act aims to remove a requirement for switching studies. Opposition to the bill is expected, but if passed how much will the Act move the biosimilars needle in the country? Scrip spoke to experts to gauge its likely impact.
About mid-July, Senator Mike Lee and a few other senators re-introduced draft legislation in the US that would stop the Food and Drug Administration (FDA) from requiring switching studies for biosimilars to obtain an interchangeability designation.
If the draft Red Tape Elimination Act is approved, it could help the cause of biosimilar penetration in the US,...
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