[Congressional Bills 117th Congress]
[From the U.S. Government Publishing Office]
[S. 6 Introduced in Senate (IS)]

<DOC>






117th CONGRESS
  2d Session
                                  S. 6

       To improve the requirements for making a determination of 
 interchangeability of a biological product and its reference product.


_______________________________________________________________________


                   IN THE SENATE OF THE UNITED STATES

                           November 17, 2022

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

_______________________________________________________________________

                                 A BILL


 
       To improve the requirements for making a determination of 
 interchangeability of a biological product and its reference product.

    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 ``Biosimilar Red Tape Elimination 
Act''.

SEC. 2. BIOSIMILAR BIOLOGICAL PRODUCTS.

    Section 351(k) of the Public Health Service Act (42 U.S.C. 262(k)) 
is amended--
            (1) in paragraph (2)(A)(i)(I)(bb), by striking ``; and'' 
        and inserting ``; or''; and
            (2) in paragraph (4)--
                    (A) at the end of subparagraph (A)(ii), by striking 
                ``; and'' and inserting a period;
                    (B) by striking ``sufficient to show'' and all that 
                follows through ``(A) the biological product--'' and 
                inserting ``sufficient to show that the biological 
                product--'';
                    (C) by striking ``Upon review of an'' and inserting 
                the following:
                    ``(A) In general.--Upon review of an''; and
                    (D) by amending subparagraph (B) to read as 
                follows:
                    ``(B) Certain studies not required.--The Secretary 
                may not require, for a determination of 
                interchangeability described in subparagraph (A), that 
                a biological product undergo studies that assess the 
                risks of alternating or switching between use of the 
                biological product and the reference product.''.
                                 <all>