135 STAT. 254 PUBLIC LAW 117–8—APR. 23, 2021 Public Law 117–8 117th Congress An Act 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 Representatives of the United States of America in Congress assembled, SECTION 1. SHORT TITLE. This Act may be cited as the ‘‘Advancing Education on Biosimilars Act of 2021’’. SEC. 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: ‘‘SEC. 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 rel- evant 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 bio- similar biological products and interchangeable biosimilar biological products licensed under section 351(k) and ref- erence products (as defined in section 351(i)), including the standards for review and licensing of each such type of biological product. 42 USC 263–1. 42 USC 201 note. Advancing Education on Biosimilars Act of 2021. Apr. 23, 2021 [S. 164] VerDate Sep 11 2014 01:48 May 01, 2021 Jkt 019139 PO 00008 Frm 00001 Fmt 6580 Sfmt 6581 E:\PUBLAW\PUBL008.117 PUBL008 kcroghan on LAP7511N33PROD with PUBLAWS 135 STAT. 255 PUBLIC LAW 117–8—APR. 23, 2021 LEGISLATIVE HISTORY—S. 164: CONGRESSIONAL RECORD, Vol. 167 (2021): Mar. 3, considered and passed Senate. Apr. 14, considered and passed House. Æ ‘‘(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 tool- kits, or other formats as appropriate and applicable; and ‘‘(B) tailored for the unique needs of health care pro- viders, 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 pro- grams that advance the education of such providers on the pre- scribing of, and relevant clinical considerations with respect to, biological products, including biosimilar biological products and interchangeable biosimilar biological products.’’. Approved April 23, 2021. VerDate Sep 11 2014 01:48 May 01, 2021 Jkt 019139 PO 00008 Frm 00002 Fmt 6580 Sfmt 6580 E:\PUBLAW\PUBL008.117 PUBL008 kcroghan on LAP7511N33PROD with PUBLAWS