{"format":1,"id":"117-s-164","congress":117,"number":"S. 164","kind":"bill","group":"bills","title":"Advancing Education on Biosimilars Act of 2021","title_source":"Short Titles as Enacted","official_title":"A bill to educate health care providers and the public on biosimilar biological products, and for other purposes.","titles":[{"type":"Official Title as Introduced","title":"A bill to educate health care providers and the public on biosimilar biological products, and for other purposes."},{"type":"Short Titles from ENR (Enrolled) bill text","title":"Advancing Education on Biosimilars Act of 2021"},{"type":"Display Title","title":"Advancing Education on Biosimilars Act of 2021"},{"type":"Short Title(s) as Introduced","title":"Advancing Education on Biosimilars Act of 2021"},{"type":"Short Title(s) as Passed Senate","title":"Advancing Education on Biosimilars Act of 2021"},{"type":"Short Titles as Enacted","title":"Advancing Education on Biosimilars Act of 2021"},{"type":"Short Titles as Passed House","title":"Advancing Education on Biosimilars Act of 2021"}],"outcome":"became_law","law_number":"Public Law 117-8","introduced":"2021-02-02","chambers":{"house":{"status":"roll_call","date":"2021-04-14","vote":{"id":"117-2021-h101","question":"On Motion to Suspend the Rules and Pass","title":"Advancing Education on Biosimilars Act","result":"Passed","yea":412,"nay":8,"present":0,"not_voting":9,"source":"https://clerk.house.gov/evs/2021/roll101.xml"}},"senate":{"status":"voice","date":"2021-03-03","vote":null,"how":"unanimous_consent","words":"Passed/agreed to in Senate: Passed Senate without amendment by Unanimous Consent.(text: CR S1021)"}},"president":{"status":"signed","date":"2021-04-23"},"vice_president_tie_breaker":null,"latest_action":{"text":"Became Public Law No: 117-8.","date":"2021-04-23"},"nominees":null,"amendments":[],"other_votes":[],"crs_summary":{"date":"2021-04-23","stage":"Public Law","blocks":[{"k":"h","t":"Advancing Education on Biosimilars Act of 2021"},{"k":"p","t":"This bill requires the Food and Drug Administration (FDA) to advance education and awareness among health care providers about biological products as appropriate, including by developing or improving continuing education programs that address the prescribing of biological products and biosimilars. (A biosimilar is a biological product that is highly similar to an FDA-approved reference biological product and has no clinically meaningful differences from that reference product.)"},{"k":"p","t":"The FDA may also maintain and operate a website to provide educational materials about biological products."}],"words":89},"summary":{"main_subject":{"text":"Amends the Public Health Service Act to authorize and direct the Secretary of Health and Human Services to provide education about biological products, including biosimilar and interchangeable biosimilar biological products, to health care providers, patients, and caregivers.","cites":[{"label":"Sec. 2","href":"https://www.congress.gov/bill/117th-congress/senate-bill/164/text/enr#idB91E21E39B0640589EDCEDC1B897872A:~:text=2.%20Education%20on%20biological%20products"}]},"core_areas":["Educational website on biological products, biosimilar biological products and interchangeable biosimilar biological products","Continuing education programs for health care providers on prescribing biological products"],"what_it_does":[{"text":"Allows the Secretary to maintain and operate an internet website with educational materials for health care providers, patients, and caregivers on the meaning of terms and the standards for review and licensing of biological products.","cite":{"label":"Sec. 2","href":"https://www.congress.gov/bill/117th-congress/senate-bill/164/text/enr#idB91E21E39B0640589EDCEDC1B897872A:~:text=2.%20Education%20on%20biological%20products"}},{"text":"Provides that the website materials may include explanations of key terms such as biosimilar and interchangeable, information on development programs for biological products, and an explanation of how adverse events are reported.","cite":{"label":"Sec. 2","href":"https://www.congress.gov/bill/117th-congress/senate-bill/164/text/enr#idB91E21E39B0640589EDCEDC1B897872A:~:text=2.%20Education%20on%20biological%20products"}},{"text":"Provides that the materials may be offered in formats such as webinars, continuing education modules, videos, fact sheets, infographics, and stakeholder toolkits, and may be tailored to different audiences.","cite":{"label":"Sec. 2","href":"https://www.congress.gov/bill/117th-congress/senate-bill/164/text/enr#idB91E21E39B0640589EDCEDC1B897872A:~:text=2.%20Education%20on%20biological%20products"}},{"text":"Requires the Secretary to continue to publish the action package or the summary review of each biological product licensed under subsection (a) or (k) of section 351.","cite":{"label":"Sec. 2","href":"https://www.congress.gov/bill/117th-congress/senate-bill/164/text/enr#idB91E21E39B0640589EDCEDC1B897872A:~:text=2.%20Education%20on%20biological%20products"}},{"text":"States that the website provision does not authorize disclosure of trade secrets, confidential commercial or financial information, or other matter described in section 552(b) of title 5.","cite":{"label":"Sec. 2","href":"https://www.congress.gov/bill/117th-congress/senate-bill/164/text/enr#idB91E21E39B0640589EDCEDC1B897872A:~:text=2.%20Education%20on%20biological%20products"}},{"text":"Requires the Secretary to advance education and awareness among health care providers about biological products, as appropriate, including by developing or improving continuing education programs on prescribing them.","cite":{"label":"Sec. 2","href":"https://www.congress.gov/bill/117th-congress/senate-bill/164/text/enr#idB91E21E39B0640589EDCEDC1B897872A:~:text=2.%20Education%20on%20biological%20products"}}],"unexpected":[],"version":{"type":"Enrolled Bill","date":null,"rule":"enrolled","href":"https://www.congress.gov/bill/117th-congress/senate-bill/164/text/enr"},"current":true,"model":"claude-sonnet-5-5","approved":"2026-10-15","approved_by":"checks"},"sources":{"congress_gov":"https://www.congress.gov/bill/117th-congress/senate-bill/164","text":"https://www.congress.gov/bill/117th-congress/senate-bill/164/text"},"card":{"image":"card/item/117-s-164.png","v":"e97635bf876d","alt":"Votes on Record. S. 164, 117th Congress: Advancing Education on Biosimilars Act of 2021. House: 412 Yea, 8 Nay. Senate: unanimous consent. Outcome: Became law, 23 Apr 2021."}}