S. 164Senate117th Congress (2021-2023)Enacted

Advancing Education on Biosimilars Act of 2021

Introduced February 2, 2021

AI-Generated Summary

Updated February 7, 2026 at 10:01 PM UTC

The Advancing Education on Biosimilars Act of 2021 directs the Health and Human Services Secretary to create and run an online resource that teaches health‑care providers, patients, and caregivers about biosimilar and interchangeable biological products. It also requires the development of continuing‑education programs for providers on prescribing and clinical considerations. The bill mainly affects clinicians, patients, caregivers, and anyone involved in the use of biological medicines.

Key Provisions

  • The Secretary must maintain an internet website offering educational materials that explain biosimilar terminology, licensing standards, development programs, clinical considerations, adverse‑event reporting, and how biosimilars relate to reference products.
  • Educational content can be delivered as webinars, continuing‑education modules, videos, fact sheets, infographics, toolkits, or other formats and tailored to different audiences.
  • The website must also publish the action package and summary review for each biological product licensed under the relevant sections of the Public Health Service Act.
  • The Secretary must develop or improve continuing‑education programs to increase provider awareness and knowledge about prescribing biosimilars and interchangeable products.
  • The law prohibits the disclosure of trade secrets, confidential commercial, or financial information in the educational materials.

Legislative Activity

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18 earlier actions
Became Law Latest Action

Became Public Law No: 117-8.

April 23, 2021

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SenateIntro Referral

Introduced in Senate

February 2, 2021

SenateIntro Referral

Read twice and referred to the Committee on Health, Education, Labor, and Pensions.

February 2, 2021

SenateCommittee

Senate Committee on Health, Education, Labor, and Pensions discharged by Unanimous Consent.(consideration: CR S1021)

March 3, 2021

SenateDischarge

Senate Committee on Health, Education, Labor, and Pensions discharged by Unanimous Consent. (consideration: CR S1021)

March 3, 2021

SenateFloor

Passed Senate without amendment by Unanimous Consent. (text: CR S1021)

March 3, 2021

SenateFloor

Message on Senate action sent to the House.

March 8, 2021

HouseFloor

Received in the House.

March 8, 2021 • 2:16 PM

HouseFloor

Held at the desk.

March 8, 2021 • 2:24 PM

HouseFloor

Mr. Pallone moved to suspend the rules and pass the bill.

April 14, 2021 • 1:10 PM

HouseFloor

Considered under suspension of the rules. (consideration: CR H1754-1755)

April 14, 2021 • 1:11 PM

HouseFloor

DEBATE - The House proceeded with forty minutes of debate on S. 164.

April 14, 2021 • 1:11 PM

HouseFloor

At the conclusion of debate, the Yeas and Nays were demanded and ordered. Pursuant to the provisions of clause 8, rule XX, the Chair announced that further proceedings on the motion would be postponed.

April 14, 2021 • 1:17 PM

HouseFloor

Considered as unfinished business. (consideration: CR H1783-1784)

April 14, 2021 • 5:20 PM

SenateFloor

Passed/agreed to in House: On motion to suspend the rules and pass the bill Agreed to by the Yeas and Nays: (2/3 required): 412 - 8 (Roll no. 101).(text: CR H1754)

April 14, 2021 • 5:51 PM

HouseFloor

On motion to suspend the rules and pass the bill Agreed to by the Yeas and Nays: (2/3 required): 412 - 8 (Roll no. 101). (text: CR H1754)

April 14, 2021 • 5:51 PM

HouseFloor

Motion to reconsider laid on the table Agreed to without objection.

April 14, 2021 • 5:51 PM

President

Presented to President.

April 20, 2021

Became Law

Signed by President.

April 23, 2021

Became Law

Became Public Law No: 117-8.

April 23, 2021

Floor Debate

6 members

What members said about S. 164 on the floor

4 Republicans2 Democrats
Frank Pallone, Jr.
Rep. Frank Pallone, Jr.D-NJ-6 · Apr 14, 2021

Mr. Speaker, I move to suspend the rules and pass the bill (S. 164) to educate health care providers and the public on biosimilar biological products, and for other purposes. Mr. Speaker, I ask…

Gus M. Bilirakis
Rep. Gus M. BilirakisR-FL-12 · Apr 14, 2021

Mr. Speaker, I yield myself such time as I may consume. Mr. Speaker, I rise today in support of S. 164, the Advancing Education on Biosimilars Act. This bill is a bipartisan companion to H.R. 1873,…

Larry Bucshon
Rep. Larry BucshonR-IN-8 · Apr 14, 2021

Mr. Speaker, I would like to speak in support of S. 164, the Advancing Education on Biosimilars Act of 2021, which is the Senate companion of H.R. 1873, a bill that I introduced with my friend and…

Jodey C. Arrington
Rep. Jodey C. ArringtonR-TX-19 · Apr 14, 2021

Mr. Speaker, I was unavoidably detained. Had I been present, I would have voted ``yea'' on rollcall No. 101. members recorded pursuant to house resolution 8, 117th congress Allred (Wexton) Babin…

Richard J. Durbin
Sen. Richard J. DurbinD-IL · Mar 3, 2021

Madam President, I ask unanimous consent that the Committee on Health, Education, Labor, and Pensions be discharged from further consideration of S. 164 and the Senate proceed to its immediate…

Show 1 more
Ben Cline
Rep. Ben ClineR-VA-6 · Apr 14, 2021

Mr. Speaker, on that I demand the yeas and nays.

Bill Text

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One Hundred Seventeenth Congress of the United States of America

1st Session

Begun and held at the City of Washington on Sunday, the third day of January, two thousand and twenty one

S. 164

AN ACT

To educate health care providers and the public on biosimilar biological products, and for other purposes.

1.

Short title

This Act may be cited as the Advancing Education on Biosimilars Act of 2021.

2.

Education on biological products

Subpart 1 of part F of title III of the Public Health Service Act (42 U.S.C. 262 et seq.) is amended by adding at the end the following:

352A.

Education on biological products

(a)

Internet website

(1)

In general

The Secretary may maintain and operate an internet website to provide educational materials for health care providers, patients, and caregivers, regarding the meaning of the terms, and the standards for review and licensing of, biological products, including biosimilar biological products and interchangeable biosimilar biological products.

(2)

Content

Educational materials provided under paragraph (1) may include—

(A)

explanations of key statutory and regulatory terms, including biosimilar and interchangeable, and clarification regarding the use of interchangeable biosimilar biological products;

(B)

information related to development programs for biological products, including biosimilar biological products and interchangeable biosimilar biological products and relevant clinical considerations for prescribers, which may include, as appropriate and applicable, information related to the comparability of such biological products;

(C)

an explanation of the process for reporting adverse events for biological products, including biosimilar biological products and interchangeable biosimilar biological products; and

(D)

an explanation of the relationship between biosimilar biological products and interchangeable biosimilar biological products licensed under section 351(k) and reference products (as defined in section 351(i)), including the standards for review and licensing of each such type of biological product.

(3)

Format

The educational materials provided under paragraph (1) may be—

(A)

in formats such as webinars, continuing education modules, videos, fact sheets, infographics, stakeholder toolkits, or other formats as appropriate and applicable; and

(B)

tailored for the unique needs of health care providers, patients, caregivers, and other audiences, as the Secretary determines appropriate.

(4)

Other information

In addition to the information described in paragraph (2), the Secretary shall continue to publish—

(A)

the action package of each biological product licensed under subsection (a) or (k) of section 351; or

(B)

the summary review of each biological product licensed under subsection (a) or (k) of section 351.

(5)

Confidential and trade secret information

This subsection does not authorize the disclosure of any trade secret, confidential commercial or financial information, or other matter described in section 552(b) of title 5.

(b)

Continuing education

The Secretary shall advance education and awareness among health care providers regarding biological products, including biosimilar biological products and interchangeable biosimilar biological products, as appropriate, including by developing or improving continuing education programs that advance the education of such providers on the prescribing of, and relevant clinical considerations with respect to, biological products, including biosimilar biological products and interchangeable biosimilar biological products.

.

Speaker of the House of Representatives

Vice President of the United States and President of the Senate