[Congressional Bills 117th Congress]
[From the U.S. Government Publishing Office]
[S. 164 Enrolled Bill (ENR)]

        S.164

                    One Hundred Seventeenth Congress

                                 of the

                        United States of America


                          AT THE FIRST SESSION

           Begun and held at the City of Washington on Sunday,
          the third day of January, two thousand and twenty one


                                 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 relevant 
        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 biosimilar 
        biological products and interchangeable biosimilar biological 
        products licensed under section 351(k) and reference products 
        (as defined in section 351(i)), including the standards for 
        review and licensing of each such type of biological product.
        ``(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 
        toolkits, or other formats as appropriate and applicable; and
            ``(B) tailored for the unique needs of health care 
        providers, 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 programs that advance the education 
of such providers on the prescribing of, and relevant clinical 
considerations with respect to, biological products, including 
biosimilar biological products and interchangeable biosimilar 
biological products.''.

                               Speaker of the House of Representatives.

                            Vice President of the United States and    
                                               President of the Senate.