Title: Lowering Costs by Improving Biosimilar Uptake Act
Policy area: Health

Summary:
Lowering Costs by Improving Biosimilar Uptake Act
This bill allows for the omission of certain information relating to the strength of a product in a biosimilar application, as determined by the Food and Drug Administration.

[Congressional Bills 117th Congress]
[From the U.S. Government Publishing Office]
[H.R. 7047 Introduced in House (IH)]

<DOC>






117th CONGRESS
  2d Session
                                H. R. 7047

To amend title III of the Public Health Service Act with respect to the 
determination by the Secretary regarding certain biosimilar application 
                   elements, and for other purposes.


_______________________________________________________________________


                    IN THE HOUSE OF REPRESENTATIVES

                             March 9, 2022

 Mr. Schrader introduced the following bill; which was referred to the 
                    Committee on Energy and Commerce

_______________________________________________________________________

                                 A BILL


 
To amend title III of the Public Health Service Act with respect to the 
determination by the Secretary regarding certain biosimilar application 
                   elements, 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 ``Lowering Costs by Improving 
Biosimilar Uptake Act''.

SEC. 2. DETERMINATION BY SECRETARY REGARDING CERTAIN BIOSIMILAR 
              APPLICATION ELEMENTS.

    Section 351(k)(2)(A)(ii) of the Public Health Service Act 
(262(k)(2)(A)(ii)) is amended to read as follows:
                            ``(ii) Determination by secretary regarding 
                        certain application elements.--
                                    ``(I) In general.--The Secretary 
                                may determine, in the Secretary's 
                                discretion, that an element described 
                                in clause (i)(I), or in clause (i)(IV) 
                                with respect to the strength of a 
                                biological product, is unnecessary in 
                                an application submitted under this 
                                subsection.
                                    ``(II) Use of determination.--If 
                                the Secretary makes a determination 
                                under this clause that information 
                                demonstrating that the strength of the 
                                biological product is the same as that 
                                of the reference product as described 
                                in clause (i)(IV) is unnecessary, the 
                                term `reference product' shall, for 
                                purposes of this section with respect 
                                to such biological product, include all 
                                applicable strengths of the reference 
                                product.''.
                                 <all>