To enhance competition for prescription drugs by increasing the ability of the Department of Justice and Federal Trade Commission to enforce existing antitrust laws regarding biologic and biosimilar products, and for other purposes.
USA115th CongressHR-6478| House
| Updated: 7/27/2018
John P. Sarbanes
Democratic Representative
Maryland
Cosponsors (1)
Health Subcommittee, Energy and Commerce Committee
- Introduced
- In Committee
- On Floor
- Passed Chamber
- Enacted
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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Timeline
Introduced in House
Referred to the House Committee on Energy and Commerce.
Referred to the Subcommittee on Health.
Health
Administrative law and regulatory proceduresCivil actions and liabilityCompetition and antitrustContracts and agencyDepartment of JusticeDrug safety, medical device, and laboratory regulationFederal Trade Commission (FTC)Prescription drugs
To enhance competition for prescription drugs by increasing the ability of the Department of Justice and Federal Trade Commission to enforce existing antitrust laws regarding biologic and biosimilar products, and for other purposes.
USA115th CongressHR-6478| House
| Updated: 7/27/2018
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.
View Full TextSuggested Questions
Get AI-generated questions to help you understand this bill better
Timeline
Introduced in House
Referred to the House Committee on Energy and Commerce.
Referred to the Subcommittee on Health.
John P. Sarbanes
Democratic Representative
Maryland
Cosponsors (1)
Health Subcommittee, Energy and Commerce Committee
Health
- Introduced
- In Committee
- On Floor
- Passed Chamber
- Enacted
Administrative law and regulatory proceduresCivil actions and liabilityCompetition and antitrustContracts and agencyDepartment of JusticeDrug safety, medical device, and laboratory regulationFederal Trade Commission (FTC)Prescription drugs