summary
Introduced
04/11/2019
04/11/2019
In Committee
04/11/2019
04/11/2019
Crossed Over
Passed
Dead
12/31/2020
12/31/2020
Introduced Session
116th Congress
Bill Summary
A bill to amend the Public Health Service Act with respect to the treatment under section 351(k)(7) of such Act (relating to exclusivity for reference products) of certain products deemed to have a biological product license pursuant to section 7002 of the Biologics Price Competition and Innovation Act of 2009. This bill excludes biological products that were initially licensed under the Federal Food, Drug, and Cosmetic Act (FD&C Act) (e.g., insulin) from the exclusivity protections that delay the licensure of biosimilar products under the Public Health Service Act (PHS Act). (The Biologics Price Competition and Innovation Act of 2009 generally requires that biological products approved under the FD&C Act are treated as though they were approved under the PHS Act through March 23, 2020.)
AI Summary
This bill amends the Public Health Service Act to exclude certain biological products, such as insulin, that were initially licensed under the Federal Food, Drug, and Cosmetic Act from the exclusivity protections that delay the licensure of biosimilar products under the Public Health Service Act. This means that these products will not receive additional exclusivity just because they are deemed to be licensed under the Public Health Service Act, and the limitation on exclusivity will apply regardless of whether the reference product was first licensed under the Public Health Service Act or deemed to be licensed under it.
Committee Categories
Health and Social Services
Sponsors (3)
Last Action
Read twice and referred to the Committee on Health, Education, Labor, and Pensions. (on 04/11/2019)
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/116th-congress/senate-bill/1140/all-info |
| BillText | https://www.congress.gov/116/bills/s1140/BILLS-116s1140is.pdf |
| Bill | https://www.congress.gov/116/bills/s1140/BILLS-116s1140is.pdf.pdf |
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