Advancing Education on Biosimilars Act of 2021

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. Be it enacted by the Senate and House of Representa- 1 tives of the United States of America in Congress assembled, 2 SECTION 1. SHORT TITLE. 3 This Act may be cited as the ‘‘Advancing Education 4 on Biosimilars Act of 2021’’. 5 SEC. 2. EDUCATION ON BIOLOGICAL PRODUCTS. 6 Subpart 1 of part F of title III of the Public Health 7 Service Act (42 U.S.C. 262 et seq.) is amended by adding 8 at the end the following: 9 VerDate Sep 11 2014 21:12 May 11, 2021 Jkt 019200 PO 00000 Frm 00001 Fmt 6652 Sfmt 6201 E:\BILLS\H1873.IH H1873 pamtmann on DSKBC07HB2PROD with BILLS 2 •HR 1873 IH ‘‘SEC. 352A. EDUCATION ON BIOLOGICAL PRODUCTS. 1 ‘‘(a) INTERNET WEBSITE.— 2 ‘‘(1) IN GENERAL.—The Secretary may main- 3 tain and operate an internet website to provide edu- 4 cational materials for health care providers, patients, 5 and caregivers, regarding the meaning of the terms, 6 and the standards for review and licensing of, bio- 7 logical products, including biosimilar biological prod- 8 ucts and interchangeable biosimilar biological prod- 9 ucts. 10 ‘‘(2) CONTENT.—Educational materials pro- 11 vided under paragraph (1) may include— 12 ‘‘(A) explanations of key statutory and 13 regulatory terms, including ‘biosimilar’ and 14 ‘interchangeable’, and clarification regarding 15 the use of interchangeable biosimilar biological 16 products; 17 ‘‘(B) information related to development 18 programs for biological products, including bio- 19 similar biological products and interchangeable 20 biosimilar biological products and relevant clin- 21 ical considerations for prescribers, which may 22 include, as appropriate and applicable, informa- 23 tion related to the comparability of such biologi- 24 cal products; 25 VerDate Sep 11 2014 21:12 May 11, 2021 Jkt 019200 PO 00000 Frm 00002 Fmt 6652 Sfmt 6201 E:\BILLS\H1873.IH H1873 pamtmann on DSKBC07HB2PROD with BILLS 3 •HR 1873 IH ‘‘(C) an explanation of the process for re- 1 porting adverse events for biological products, 2 including biosimilar biological products and 3 interchangeable biosimilar biological products; 4 and 5 ‘‘(D) an explanation of the relationship be- 6 tween biosimilar biological products and inter- 7 changeable biosimilar biological products li- 8 censed under section 351(k) and reference 9 products (as defined in section 351(i)), includ- 10 ing the standards for review and licensing of 11 each such type of biological product. 12 ‘‘(3) FORMAT.—The educational materials pro- 13 vided under paragraph (1) may be— 14 ‘‘(A) in formats such as webinars, con- 15 tinuing education modules, videos, fact sheets, 16 infographics, stakeholder toolkits, or other for- 17 mats as appropriate and applicable; and 18 ‘‘(B) tailored for the unique needs of 19 health care providers, patients, caregivers, and 20 other audiences, as the Secretary determines 21 appropriate. 22 ‘‘(4) OTHER INFORMATION.—In addition to the 23 information described in paragraph (2), the Sec- 24 retary shall continue to publish— 25 VerDate Sep 11 2014 21:12 May 11, 2021 Jkt 019200 PO 00000 Frm 00003 Fmt 6652 Sfmt 6201 E:\BILLS\H1873.IH H1873 pamtmann on DSKBC07HB2PROD with BILLS 4 •HR 1873 IH ‘‘(A) the action package of each biological 1 product licensed under subsection (a) or (k) of 2 section 351; or 3 ‘‘(B) the summary review of each biological 4 product licensed under subsection (a) or (k) of 5 section 351. 6 ‘‘(5) CONFIDENTIAL AND TRADE SECRET IN- 7 FORMATION.—This subsection does not authorize 8 the disclosure of any trade secret, confidential com- 9 mercial or financial information, or other matter de- 10 scribed in section 552(b) of title 5. 11 ‘‘(b) CONTINUING EDUCATION.—The Secretary shall 12 advance education and awareness among health care pro- 13 viders regarding biological products, including biosimilar 14 biological products and interchangeable biosimilar biologi- 15 cal products, as appropriate, including by developing or 16 improving continuing education programs that advance 17 the education of such providers on the prescribing of, and 18 relevant clinical considerations with respect to, biological 19 products, including biosimilar biological products and 20 interchangeable biosimilar biological products.’’. 21 Æ VerDate Sep 11 2014 21:12 May 11, 2021 Jkt 019200 PO 00000 Frm 00004 Fmt 6652 Sfmt 6301 E:\BILLS\H1873.IH H1873 pamtmann on DSKBC07HB2PROD with BILLS