All Roll Calls
Yes: 412 • No: 8
117-s-164117th CongressWALLET
Advancing Education on Biosimilars Act of 2021
Sponsored By: Senator Hassan, Margaret Wood [D-NH]
Became Law
Summary
Education on biosimilars to help clinicians, patients, and caregivers understand biosimilar and interchangeable biological drugs. It creates an online education program and continuing education for health care providers, and it requires publication of regulators' action packages or summary reviews while protecting trade secrets.
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- Health care providers get continuing education, webinars, and clinical materials about development pathways, review standards, prescribing considerations, comparability, and how to report adverse events.
- Patients and caregivers get an online hub with videos, fact sheets, infographics, and toolkits that explain terms like “biosimilar” and “interchangeable” and how to report problems.
- Product sponsors and the public gain continued access to each biological product’s action package or summary review, with explicit protection for trade secrets and confidential commercial information.
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Bill Overview
Analyzed Economic Effects
1 provisions identified: 1 benefits, 0 costs, 0 mixed.
More education and transparency on biosimilars
The law advances education on biologic drugs, especially biosimilars. The Secretary may run a website and offer continuing education for doctors, plus materials for patients and caregivers. Topics include what “biosimilar” and “interchangeable” mean, FDA review and licensing standards, and how to report side effects. The Secretary also publishes either the action package or a summary review for each licensed biologic. Trade secrets and confidential business information stay protected. This starts upon enactment.
Sponsors & CoSponsors
Sponsor
Hassan, Margaret Wood [D-NH]
NH • D
Cosponsors
Sen. Cassidy, Bill [R-LA]
LA • R
Sponsored 2/2/2021
Roll Call Votes
house vote • 4/14/2021
On Motion to Suspend the Rules and Pass
Yes: 412 • No: 8