Apr. 23, 2021 

[S. 164] 

42 USC 201 note. Advancing Education on Biosimilars Act of 2021. 

42 USC 263–1. 

# Public Law 117–8 117th Congress 

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. 

# An Act 

