S. 6 — Introduced in Senate

II 117th CONGRESS 2d Session S. 6 IN THE SENATE OF THE UNITED STATES November 17, 2022Mr. 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. 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. .