Title: Biologics Competition Act of 2022
Policy area: Health

Summary:
Biologics Competition Act of 2022
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.
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.

[Congressional Bills 117th Congress]
[From the U.S. Government Publishing Office]
[H.R. 8877 Introduced in House (IH)]

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117th CONGRESS
  2d Session
                                H. R. 8877

 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.


_______________________________________________________________________


                    IN THE HOUSE OF REPRESENTATIVES

                           September 19, 2022

   Mrs. Miller-Meeks (for herself, Mr. Murphy of North Carolina, Ms. 
  Barragan, 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.

    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 ``Biologics Competition Act of 2022''.

SEC. 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).
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