[Congressional Bills 117th Congress]
[From the U.S. Government Publishing Office]
[S. 4303 Introduced in Senate (IS)]

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117th CONGRESS
  2d Session
                                S. 4303

   To provide for a period of exclusivity for first interchangeable 
                          biological products.


_______________________________________________________________________


                   IN THE SENATE OF THE UNITED STATES

                              May 25, 2022

Mr. Kaine (for himself and Ms. Collins) introduced the following bill; 
     which was read twice and referred to the Committee on Health, 
                     Education, Labor, and Pensions

_______________________________________________________________________

                                 A BILL


 
   To provide for a period of exclusivity for first interchangeable 
                          biological products.

    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 ``Interchangeable Biologics Clarity 
Act''.

SEC. 2. CLARIFICATIONS TO EXCLUSIVITY PROVISIONS FOR FIRST 
              INTERCHANGEABLE BIOSIMILAR BIOLOGICAL PRODUCTS.

    Section 351(k)(6) of the Public Health Service Act (42 U.S.C. 
262(k)(6)) is amended--
            (1) in the matter preceding subparagraph (A)--
                    (A) by striking ``Upon review of'' and inserting 
                ``The Secretary shall not make approval effective of'';
                    (B) by striking ``relying on'' and inserting ``for 
                an interchangeable biological product that relies on''; 
                and
                    (C) by striking ``the Secretary shall not make a 
                determination under paragraph (4) that the second or 
                subsequent biological product is interchangeable for 
                any condition of use''; and
            (2) in the flush text that follows subparagraph (C), by 
        striking the period and inserting ``, and the term `first 
        interchangeable biosimilar biological product' means any 
        interchangeable biosimilar biological product that is approved 
        on the first day on which such a product is approved as 
        interchangeable with the reference product.''.
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