US Bill Seeks To Eliminate Biosimilar Interchangeability Trial Burden

‘Biosimilar Red Tape Elimination Act’ Would Remove Need For Switching Studies

Senator Mike Lee has introduced draft legislation in the US that would stop the FDA from requiring biosimilars to conduct “unnecessary” switching studies in order to obtain an interchangeability designation.

Scissors cutting red tape
The bill is aimed at eliminating “red tape and unnecessary studies” • Source: Shutterstock

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