Interchangeable Biologics Clarity Act

Bill: 117-s-4303
Sponsor: full_name: Sen. Kaine, Tim [D-VA]
Introduced: 2022-05-25
Policy area: Health
Latest action: action_date: 2022-05-25
text: Read twice and referred to the Committee on Health, Education, Labor, and Pensions. (Sponsor introductory remarks on measure: CR S2709-2710)

Summaries:
action_date: 2022-05-25
action_desc: Introduced in Senate
text: <p><b>Interchangeable Biologics Clarity Act</b></p> <p>This bill provides a statutory definition for<i> first interchangeable biosimilar biological product</i> and makes other technical changes with respect to the provisions that establish the corresponding periods of market exclusivity.</p>

tv_txt: II 117th CONGRESS 2d Session S. 4303 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.

1. Short title This Act may be cited as the Interchangeable Biologics Clarity Act . 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. .