I 

117TH CONGRESS 

1ST SESSION H. R. 1873 

To educate health care providers and the public on biosimilar biological 

products, and for other purposes. 

IN THE HOUSE OF REPRESENTATIVES 

MARCH 12, 2021 

Mr. BUCSHON (for himself and Mr. PETERS) introduced the following bill; 

which was referred to the Committee on Energy and Commerce 

A BILL 

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, 

3 SECTION 1. SHORT TITLE. 

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

5 on Biosimilars Act of 2021’’. 

6 SEC. 2. EDUCATION ON BIOLOGICAL PRODUCTS. 

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

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

9 at the end the following: 


pamtmann on DSKBC07HB2PROD with BILLS
2 

•HR 1873 IH

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

2 ‘‘(a) INTERNET WEBSITE.— 

3 ‘‘(1) IN GENERAL.—The Secretary may main4 tain and operate an internet website to provide edu5 cational materials for health care providers, patients, 

6 and caregivers, regarding the meaning of the terms, 

7 and the standards for review and licensing of, bio8 logical products, including biosimilar biological prod9 ucts and interchangeable biosimilar biological prod10 ucts. 

11 ‘‘(2) CONTENT.—Educational materials pro12 vided under paragraph (1) may include— 

13 ‘‘(A) explanations of key statutory and 

14 regulatory terms, including ‘biosimilar’ and 

15 ‘interchangeable’, and clarification regarding 

16 the use of interchangeable biosimilar biological 

17 products; 

18 ‘‘(B) information related to development 

19 programs for biological products, including bio20 similar biological products and interchangeable 

21 biosimilar biological products and relevant clin22 ical considerations for prescribers, which may 

23 include, as appropriate and applicable, informa24 tion related to the comparability of such biologi25 cal products; 


pamtmann on DSKBC07HB2PROD with BILLS
3 

•HR 1873 IH

1 ‘‘(C) an explanation of the process for re2 porting adverse events for biological products, 

3 including biosimilar biological products and 

4 interchangeable biosimilar biological products; 

5 and 

6 ‘‘(D) an explanation of the relationship be7 tween biosimilar biological products and inter8 changeable biosimilar biological products li9 censed under section 351(k) and reference 

10 products (as defined in section 351(i)), includ11 ing the standards for review and licensing of 

12 each such type of biological product. 

13 ‘‘(3) FORMAT.—The educational materials pro14 vided under paragraph (1) may be— 

15 ‘‘(A) in formats such as webinars, con16 tinuing education modules, videos, fact sheets, 

17 infographics, stakeholder toolkits, or other for18 mats as appropriate and applicable; and 

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

20 health care providers, patients, caregivers, and 

21 other audiences, as the Secretary determines 

22 appropriate. 

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

24 information described in paragraph (2), the Sec25 retary shall continue to publish— 


pamtmann on DSKBC07HB2PROD with BILLS
4 

•HR 1873 IH

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

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

3 section 351; or 

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

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

6 section 351. 

7 ‘‘(5) CONFIDENTIAL AND TRADE SECRET IN8 FORMATION.—This subsection does not authorize 

9 the disclosure of any trade secret, confidential com10 mercial or financial information, or other matter de11 scribed in section 552(b) of title 5. 

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

13 advance education and awareness among health care pro14 viders regarding biological products, including biosimilar 

15 biological products and interchangeable biosimilar biologi16 cal products, as appropriate, including by developing or 

17 improving continuing education programs that advance 

18 the education of such providers on the prescribing of, and 

19 relevant clinical considerations with respect to, biological 

20 products, including biosimilar biological products and 

21 interchangeable biosimilar biological products.’’. 

Æ 


pamtmann on DSKBC07HB2PROD with BILLS