S 1414
Expedited Access to Biosimilars Act
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- Passed Senate
- Passed House
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- Became Law
Bill overview
This bill, the Expedited Access to Biosimilars Act, aims to speed up the approval process for biosimilar medications. It changes how the Food and Drug Administration (FDA) evaluates these drugs, allowing them to be approved based on demonstrating safety, purity, and potency without needing extensive studies on immunogenicity, pharmacodynamics, or comparative clinical efficacy. This would reduce the time and cost associated with bringing biosimilars to market, potentially lowering the cost of these medications for patients.
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