116TH CONGRESS 

2D SESSION S. 1681 

AN ACT 

To educate health care providers and the public on biosimilar 

biological products, and for other purposes. 

1 Be it enacted by the Senate and House of Representa2 tives of the United States of America in Congress assembled, 
2 

†S 1681 ES

1 SECTION 1. SHORT TITLE. 

2 This Act may be cited as the ‘‘Advancing Education 

3 on Biosimilars Act of 2020’’. 

4 SEC. 2. EDUCATION ON BIOLOGICAL PRODUCTS. 

5 Subpart 1 of part F of title III of the Public Health 

6 Service Act (42 U.S.C. 262 et seq.) is amended by adding 

7 at the end the following: 

8 ‘‘SEC. 352A. EDUCATION ON BIOLOGICAL PRODUCTS. 

9 ‘‘(a) INTERNET WEBSITE.— 

10 ‘‘(1) IN GENERAL.—The Secretary may main11 tain and operate an internet website to provide edu12 cational materials for health care providers, patients, 

13 and caregivers, regarding the meaning of the terms, 

14 and the standards for review and licensing of, bio15 logical products, including biosimilar biological prod16 ucts and interchangeable biosimilar biological prod17 ucts. 

18 ‘‘(2) CONTENT.—Educational materials pro19 vided under paragraph (1) may include— 

20 ‘‘(A) explanations of key statutory and 

21 regulatory terms, including ‘biosimilar’ and 

22 ‘interchangeable’, and clarification regarding 

23 the use of interchangeable biosimilar biological 

24 products; 

25 ‘‘(B) information related to development 

26 programs for biological products, including bio-
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†S 1681 ES

1 similar biological products and interchangeable 

2 biosimilar biological products and relevant clin3 ical considerations for prescribers, which may 

4 include, as appropriate and applicable, informa5 tion related to the comparability of such biologi6 cal products; 

7 ‘‘(C) an explanation of the process for re8 porting adverse events for biological products, 

9 including biosimilar biological products and 

10 interchangeable biosimilar biological products; 

11 and 

12 ‘‘(D) an explanation of the relationship be13 tween biosimilar biological products and inter14 changeable biosimilar biological products li15 censed under section 351(k) and reference 

16 products (as defined in section 351(i)), includ17 ing the standards for review and licensing of 

18 each such type of biological product. 

19 ‘‘(3) FORMAT.—The educational materials pro20 vided under paragraph (1) may be— 

21 ‘‘(A) in formats such as webinars, con22 tinuing education modules, videos, fact sheets, 

23 infographics, stakeholder toolkits, or other for24 mats as appropriate and applicable; and 
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†S 1681 ES

1 ‘‘(B) tailored for the unique needs of 

2 health care providers, patients, caregivers, and 

3 other audiences, as the Secretary determines 

4 appropriate. 

5 ‘‘(4) OTHER INFORMATION.—In addition to the 

6 information described in paragraph (2), the Sec7 retary shall continue to publish— 

8 ‘‘(A) the action package of each biological 

9 product licensed under subsection (a) or (k) of 

10 section 351; or 

11 ‘‘(B) the summary review of each biological 

12 product licensed under subsection (a) or (k) of 

13 section 351. 

14 ‘‘(5) CONFIDENTIAL AND TRADE SECRET IN15 FORMATION.—This subsection does not authorize 

16 the disclosure of any trade secret, confidential com17 mercial or financial information, or other matter de18 scribed in section 552(b) of title 5. 

19 ‘‘(b) CONTINUING EDUCATION.—The Secretary shall 

20 advance education and awareness among health care pro21 viders regarding biological products, including biosimilar 

22 biological products and interchangeable biosimilar biologi23 cal products, as appropriate, including by developing or 

24 improving continuing education programs that advance 

25 the education of such providers on the prescribing of, and 
5 

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1 relevant clinical considerations with respect to, biological 

2 products, including biosimilar biological products and 

3 interchangeable biosimilar biological products.’’. 

Passed the Senate December 17, 2020. 

Attest: 

Secretary. 
116TH CONGRESS 

2D SESSION S. 1681 

AN ACT 

To educate health care providers and the public on 

poses. biosimilar biological products, and for other pur-