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Study to streamline access to cheaper interchangeable biosimilar drugs

This law requires the Department of Health to conduct a detailed study on the process of designating biosimilar biological products as interchangeable. The goal is to understand the challenges and data required for this status. Streamlining access to interchangeable biosimilars could increase market competition, potentially resulting in lower treatment costs for citizens.
Key points
Mandates the FDA to conduct a study on how biosimilar drugs achieve "interchangeable" status.
The report must assess the data needed for approval and the challenges faced by manufacturers.
Increased approval of interchangeable biosimilars could lead to lower prices for expensive biological medicines.
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Additional Information
A bill to require the Secretary of Health and Human Services to conduct a study on the designation of biosimilar biological products as interchangeable.
Print number: S 1522
Sponsor: Sen. Marshall, Roger [R-KS]
Process start date: 2023-05-10