S 2305 United States Senate · 118th Congress

Biosimilar Red Tape Elimination Act

This bill changes how biosimilar drugs are approved by automatically considering them interchangeable with brand-name drugs, removing a previous requirement for separate approval. It requires the FDA to brief congressional health committees before demanding certain safety studies on switching between biosimilars and reference drugs. The law affects drug manufacturers seeking FDA approval for biosimilars and the FDA itself. These changes apply only to new applications approved after the bill's enactment.
Bill status in committee 1 of 4 stages cleared
Introduction
Jul 2023
Committee Review
Floor Vote
President
Introduced Jul 13, 2023 Last action Jul 13, 2023
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Total actions
2
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0
Committee
1
Jul 13, 2023
Committee
Read twice and referred to the Committee on Health, Education, Labor, and Pensions.
upper
Jul 13, 2023
Introduced
Introduced in Senate
upper
1 primary · 4 co-sponsors

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