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S. 164 (117th): Advancing Education on Biosimilars Act of 2021

The text of the bill below is as of Mar 12, 2021 (Preprint (Suspension)).

                      S. 164

                    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 Representa-
2 tives of the United States of America in Congress assembled,

2 1 SECTION 1. SHORT TITLE. 2 This Act may be cited as the ‘‘Advancing Education 3 on Biosimilars Act of 2021’’. 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 main- 11 tain and operate an internet website to provide edu- 12 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, bio- 15 logical products, including biosimilar biological prod- 16 ucts and interchangeable biosimilar biological prod- 17 ucts. 18 ‘‘(2) CONTENT.—Educational materials pro- 19 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- † S 164 ES
3 1 similar biological products and interchangeable 2 biosimilar biological products and relevant clin- 3 ical considerations for prescribers, which may 4 include, as appropriate and applicable, informa- 5 tion related to the comparability of such biologi- 6 cal products; 7 ‘‘(C) an explanation of the process for re- 8 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 be- 13 tween biosimilar biological products and inter- 14 changeable biosimilar biological products li- 15 censed under section 351(k) and reference 16 products (as defined in section 351(i)), includ- 17 ing the standards for review and licensing of 18 each such type of biological product. 19 ‘‘(3) FORMAT.—The educational materials pro- 20 vided under paragraph (1) may be— 21 ‘‘(A) in formats such as webinars, con- 22 tinuing education modules, videos, fact sheets, 23 infographics, stakeholder toolkits, or other for- 24 mats as appropriate and applicable; and † S 164 ES
4 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 Sec- 7 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 IN- 15 FORMATION.—This subsection does not authorize 16 the disclosure of any trade secret, confidential com- 17 mercial or financial information, or other matter de- 18 scribed in section 552(b) of title 5. 19 ‘‘(b) CONTINUING EDUCATION.—The Secretary shall 20 advance education and awareness among health care pro- 21 viders regarding biological products, including biosimilar 22 biological products and interchangeable biosimilar biologi- 23 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 † S 164 ES
5 1 relevant clinical considerations with respect to, biological 2 products, including biosimilar biological products and 3 interchangeable biosimilar biological products.’’. Passed the Senate March 3, 2021. Attest: Secretary. † S 164 ES
117TH CONGRESS 1ST SESSION S. 164 AN ACT To educate health care providers and the public on biosimilar biological products, and for other pur- poses.