117 S6 IS: Biosimilar Red Tape Elimination Act U.S. Senate 2022-11-17 text/xml EN Pursuant to Title 17 Section 105 of the United States Code, this file is not subject to copyright protection and is in the public domain.

II117th CONGRESS2d SessionS. 6IN THE SENATE OF THE UNITED STATESNovember 17, 2022Mr. Lee introduced the following bill; which was read twice and referred to the Committee on Health, Education, Labor, and PensionsA BILLTo improve the requirements for making a determination of interchangeability of a biological product and its reference product.

1.

Short title

This Act may be cited as the Biosimilar Red Tape Elimination Act.

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..