A bill to require the Secretary of Health and Human Services to conduct a study on the designation of biosimilar biological products as interchangeable.

Subjects: Health


<html><body><pre>[Congressional Bills 118th Congress]
[From the U.S. Government Publishing Office]
[S. 1522 Introduced in Senate (IS)]

&lt;DOC&gt;






118th CONGRESS
  1st Session
                                S. 1522

  To require the Secretary of Health and Human Services to conduct a 
     study on the designation of biosimilar biological products as 
                            interchangeable.


_______________________________________________________________________


                   IN THE SENATE OF THE UNITED STATES

                              May 10, 2023

 Mr. Marshall introduced the following bill; which was read twice and 
  referred to the Committee on Health, Education, Labor, and Pensions

_______________________________________________________________________

                                 A BILL


 
  To require the Secretary of Health and Human Services to conduct a 
     study on the designation of biosimilar biological products as 
                            interchangeable.

    Be it enacted by the Senate and House of Representatives of the 
United States of America in Congress assembled,

SECTION 1. STUDY ON THE SUBSTITUTION OF INTERCHANGEABLE BIOLOGICAL 
              PRODUCTS.

    (a) Report on Biosimilar Biological Product Interchangeability.--
Not later than 4 years after the date of enactment of this Act, the 
Secretary of Health and Human Services (referred to in this section as 
the ``Secretary''), acting through the Commissioner of Food and Drugs, 
shall submit to the Committee on Health, Education, Labor, and Pensions 
of the Senate and the Committee on Energy and Commerce of the House of 
Representatives a report on the designation of biosimilar biological 
products as interchangeable, under section 351(k)(4) of the Public 
Health Service Act (42 U.S.C. 262(k)(4)). Such report shall--
            (1) describe any challenges faced by manufacturers in 
        developing and obtaining approval under section 351(k) of such 
        Act for biosimilar biological products that receive such 
        interchangeability designation;
            (2) summarize the experience of the Food and Drug 
        Administration in reviewing applications for biosimilar 
        biological products that seek an interchangeability 
        designation, including compared to applications for biosimilar 
        biological products under such section 351(k) that do not seek 
        such designation;
            (3) summarize, at a high level, the data and information 
        that the Food and Drug Administration has reviewed to support 
        applications for interchangeability under section 351(k)(4) of 
        such Act, including data from switching studies, and the 
        differences between the findings from such data and information 
        compared to the data and information that the Food and Drug 
        Administration has reviewed for biosimilar biological products 
        that have not received a designation of interchangeability;
            (4) describe the existing authority of the Food and Drug 
        Administration to determine, on a case-by-case basis, the 
        evidence needed to support an interchangeability designation, 
        and how the Food and Drug Administration has used such 
        authority, including the factors that the agency may consider 
        when making those judgements;
            (5) describe how the Food and Drug Administration has 
        considered real-world evidence or other data and information, 
        including from use of the biological product in other 
        countries, in determining whether a biosimilar biological 
        product meets the criteria for the interchangeability 
        designation;
            (6) describe the differences between the regulatory and 
        scientific considerations for determining a biological product 
        to be interchangeable under section 351(k)(4) of such Act (42 
        U.S.C. 262(k)(4)) and the system for assigning therapeutic 
        equivalence ratings to drugs approved under section 505 of the 
        Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355); and
            (7) assess the uptake of biosimilar biological products, 
        and the impact of the efforts of the Food and Drug 
        Administration to improve adoption of biosimilar biological 
        products through multimedia education and curriculum materials.
    (b) Stakeholder Input.--For purposes of developing the report 
described in subsection (a), the Secretary may convene workshops or 
listening sessions, establish dockets to receive public comment, or use 
other means to obtain input from interested stakeholders.
    (c) Information Disclosure.--Nothing in this section shall be 
construed to authorize the disclosure of information that is prohibited 
from disclosure under section 301(j) of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 331(j)) or section 1905 of title 18, United 
States Code, or subject to withholding under paragraph (4) of section 
552(b) of title 5, United States Code (commonly referred to as the 
``Freedom of Information Act'').
                                 &lt;all&gt;
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