Biosimilar Red Tape Elimination Act
This bill removes and otherwise modifies certain requirements related to the approval of biosimilars, such as prohibiting the Food and Drug Administration from requiring studies that assess the risks of switching between the biosimilar and the reference biologic.
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.''.
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Biosimilar Red Tape Elimination Act
A bill to improve the requirements for making a determination of interchangeability of a biological product and its reference product.
Biosimilar Red Tape Elimination Act
Sen. Lee, Mike