S. 1140 · 116th Congress
Protecting Access to Biosimilars Act of 2019
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Never voted on. It didn't reach a floor vote before the 116th Congress ended, so it expired. A bill has to be introduced again to be considered in a new Congress.
D
SmithSponsor2 cosponsors · 2 R
1 signed on when it was introduced; the rest joined later. Cosponsors who withdrew aren't shown.
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).
What it does: CRS summary · Introduced in Senate · Apr 11, 2019
Protecting Access to Biosimilars Act of 2019
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.)
Written by the nonpartisan Congressional Research Service. All summary versions on Congress.gov
About this bill and sources
Official title: Protecting Access to Biosimilars Act of 2019
Latest action (Apr 11, 2019): Read twice and referred to the Committee on Health, Education, Labor, and Pensions.
Policy area: Health · Origin: Senate · Introduced: Apr 11, 2019
Official page on Congress.gov · Bill text (GovInfo) · Status record (XML)
No recorded floor vote found.