United States · Bill · HR
H.R. 2011 (116th)
Protecting Access to Biosimilars Act of 2019
Introduced
1 April 2019
Last action
—
Status
Referred to the Subcommittee on Health.
Sponsors
—
Subjects
Discovery layer
Source updated
5 December 2025
Summary
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.)
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Versions
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Documents
3 official files
Introduced in House (text)
Introduced in House · EN · 1 April 2019
Introduced in House (PDF)
Introduced in House · EN · 1 April 2019
Introduced in House
summary · EN · 1 April 2019
Sponsors
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Related records
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Sources
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- Official source: https://www.congress.gov/bill/116th-congress/house-bill/2011
- Open data entity: https://api.congress.gov/v3/bill/116/hr/2011