summary
Introduced
05/25/2022
05/25/2022
In Committee
05/25/2022
05/25/2022
Crossed Over
Passed
Dead
01/03/2023
01/03/2023
Introduced Session
117th Congress
Bill Summary
A BILL To provide for a period of exclusivity for first interchangeable biological products.
AI Summary
This bill, the Interchangeable Biologics Clarity Act, aims to provide a period of exclusivity for the first interchangeable biological product approved by the Food and Drug Administration (FDA). Specifically, the bill amends the Public Health Service Act to clarify that the FDA shall not approve a second or subsequent interchangeable biological product that relies on the same reference product as the first approved interchangeable biological product. This ensures that the first interchangeable biosimilar biological product, which is defined as the first such product approved, has a period of exclusivity before additional interchangeable versions can be approved.
Committee Categories
Health and Social Services
Sponsors (3)
Last Action
Read twice and referred to the Committee on Health, Education, Labor, and Pensions. (Sponsor introductory remarks on measure: CR S2709-2710) (on 05/25/2022)
Official Document
bill text
bill summary
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bill summary
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bill summary
| Document Type | Source Location |
|---|---|
| State Bill Page | https://www.congress.gov/bill/117th-congress/senate-bill/4303/all-info |
| BillText | https://www.congress.gov/117/bills/s4303/BILLS-117s4303is.pdf |
| Bill | https://www.congress.gov/117/bills/s4303/BILLS-117s4303is.pdf.pdf |
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