Protecting Access to Biosimilars Act of 2019
Have a question about what this bill does? Ask in plain English; the answer is drawn from the bill's actual text and official record, and it'll tell you when something isn't in the text rather than guess.
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.)
Read twice and referred to the Committee on Health, Education, Labor, and Pensions.
- Introduced in Senate Formatted Text PDF Formatted XML
Cite this page
U.S. Congress. (2026). S. 1140: Protecting Access to Biosimilars Act of 2019. 116th Congress. Open America. https://openamerica.io/bill/116-S-1140/
"S. 1140: Protecting Access to Biosimilars Act of 2019." 116th Congress, 2026, Open America, https://openamerica.io/bill/116-S-1140/.
S. 1140, 116th Cong. (2026), https://openamerica.io/bill/116-S-1140/.
[S. 1140: Protecting Access to Biosimilars Act of 2019](https://openamerica.io/bill/116-S-1140/)