Bill Sponsor
BILLSPONSOR
Bill Sponsor
Politicians
Bills
Senate Bill 4303
117th Congress(2021-2022)
Interchangeable Biologics Clarity Act
Introduced
Introduced
Introduced in Senate on May 25, 2022
Overview
Text
Introduced in Senate 
May 25, 2022
No Linkage Found
About Linkage
Multiple bills can contain the same text. This could be an identical bill in the opposite chamber or a smaller bill with a section embedded in a larger bill.
Bill Sponsor regularly scans bill texts to find sections that are contained in other bill texts. When a matching section is found, the bills containing that section can be viewed by clicking "View Bills" within the bill text section.
Bill Sponsor is currently only finding exact word-for-word section matches. In a future release, partial matches will be included.
Introduced in Senate(May 25, 2022)
May 25, 2022
No Linkage Found
About Linkage
Multiple bills can contain the same text. This could be an identical bill in the opposite chamber or a smaller bill with a section embedded in a larger bill.
Bill Sponsor regularly scans bill texts to find sections that are contained in other bill texts. When a matching section is found, the bills containing that section can be viewed by clicking "View Bills" within the bill text section.
Bill Sponsor is currently only finding exact word-for-word section matches. In a future release, partial matches will be included.
Jump To
S. 4303 (Introduced-in-Senate)


117th CONGRESS
2d Session
S. 4303


To provide for a period of exclusivity for first interchangeable biological products.

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.

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 “Interchangeable Biologics Clarity Act”.

SEC. 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.”.