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US Bill Takes Another Shot At Biosimilar Interchangeability

Draft Legislation Would Classify All Approved Biosimilars As Interchangeable

 
• By Dave Wallace

Draft legislation reintroduced in the US is seeking to remove the need for switching studies to demonstrate biosimilar interchangeability, making all approved biosimilars automatically interchangeable.

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Legislators want to remove the trial burden for interchangeability • Source: Vectors.1 / Alamy Stock Vector

The US interchangeability designation for biosimilars is once again in the crosshairs of legislators, after a bill aimed at removing the need for switching studies in order for a product to gain approval as an interchangeable biosimilar was reintroduced in the country’s senate.

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