H.R.6478 - Biosimilars Competition Act of 2018115th Congress (2017-2018)
|Sponsor:||Rep. Sarbanes, John P. [D-MD-3] (Introduced 07/23/2018)|
|Committees:||House - Energy and Commerce|
|Latest Action:||House - 07/27/2018 Referred to the Subcommittee on Health. (All Actions)|
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Summary: H.R.6478 — 115th Congress (2017-2018)All Information (Except Text)
Introduced in House (07/23/2018)
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.