United States · Bill · HR
H.R. 6478 (115th)
Biosimilars Competition Act of 2018
Introduced
23 July 2018
Last action
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Status
Referred to the Subcommittee on Health.
Sponsors
—
Subjects
Discovery layer
Source updated
11 August 2025
Summary
Biosimilars Competition Act of 2018 This bill amends the Public Health Service Act to require a biologic manufacturer and a biosimilar drug manufacturer to provide notification to the Department of Justice and the Federal Trade Commission regarding certain pharmaceutical agreements. The agreements requiring notice are those related to the manufacturer, marketing or sale of the biosimilar product or the reference product. Biosimilars are biological products approved by the Food and Drug Administration based on their similarity to an already-approved biological product.
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Documents
3 official files
Introduced in House (text)
Introduced in House (text)
Introduced in House · EN · 23 July 2018
Introduced in House (PDF)
Introduced in House · EN · 23 July 2018
Introduced in House
summary · EN · 23 July 2018
Sponsors
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Sources
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- Official source: https://www.congress.gov/bill/115th-congress/house-bill/6478
- Open data entity: https://api.congress.gov/v3/bill/115/hr/6478