Biologics Competition Act of 2022

Bill: 117-hr-8877
Sponsor: full_name: Rep. Miller-Meeks, Mariannette [R-IA-2]
Introduced: 2022-09-19
Policy area: Health
Latest action: action_date: 2022-09-20
text: Referred to the Subcommittee on Health.

Summaries:
action_date: 2022-09-19
action_desc: Introduced in House
text: <p><b>Biologics Competition Act of </b><b>2022</b></p> <p>This bill requires the Food and Drug Administration (FDA) to evaluate (1) the differences between the requirements that apply to interchangeable biologics and the requirements that apply to therapeutically equivalent ratings for generic drugs, and (2) the effects of these differences on the approval of interchangeable biologics. The FDA must update the Purple Book with changes that better align the ways these requirements are communicated while still maintaining each distinct approval pathway. </p> <p>The Purple Book is an FDA publication that lists approved biological products, including biosimilars and interchangeable biologics. Interchangeable biologics are biologics that may be substituted for the original product without consulting the prescriber, similar to how generic drugs may be substituted for brand-name drugs based on therapeutic equivalence.</p>

tv_txt: I 117th CONGRESS 2d Session H. R. 8877 IN THE HOUSE OF REPRESENTATIVES September 19, 2022 Mrs. Miller-Meeks (for herself, Mr. Murphy of North Carolina , Ms. Barragán , and Ms. Kuster ) introduced the following bill; which was referred to the Committee on Energy and Commerce A BILL To direct the Secretary of Health and Human Services to evaluate the extent to which the substitution of interchangeable biological products may be impeded by differences between the system for determining a biological product to be interchangeable and the system for assigning therapeutic equivalence ratings to drugs, and for other purposes.

1. Short title This Act may be cited as the Biologics Competition Act of 2022 . 2. Study on certain impediments to the substitution of interchangeable biological products Not later than 12 months after the date of enactment of this Act, the Secretary of Health and Human Services shall— (1) complete a study to evaluate the extent to which the substitution of interchangeable biological products licensed under section 351 of the Public Health Service Act ( 42 U.S.C. 262 ) may be impeded by differences between the system for determining a biological product to be interchangeable under section 351(k)(4) of such Act ( 42 U.S.C. 262(k)(4) ) and the system for assigning therapeutic equivalence ratings to drugs approved under section 505 of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 355 ); (2) submit a report to the Congress on the results of the study under paragraph (1); and (3) update the list published under section 351(k)(9)(A) of the Public Health Service Act ( 42 U.S.C. 262(k)(9)(A) ) (commonly referred to as the Purple Book ) to implement such changes as the Secretary deems necessary to harmonize the approach for communicating the substitutability of interchangeable biological products with the approach for communicating therapeutic equivalence ratings assigned to drugs, with the goals of— (A) minimizing impediments to the substitution of interchangeable biological products; and (B) maintaining the distinct pathways by which biological products are licensed under section 351 of the Public Health Service Act ( 42 U.S.C. 262 ) and drugs are approved under section 505 of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 355 ).