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

Draft legislation introduced in the US by senator Mike Lee is seeking to “increase competition within the biological drug market and reduce consumer costs” by prohibiting the US Food and Drug Administration from requiring biosimilars to undergo switching studies to receive an interchangeability designation.

According to Lee, the

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