Title: Biosimilar Insulin Access Act of 2020
Policy area: Health

Summary:
Biosimilar Insulin Access Act of 2020
This bill establishes that, if the Food and Drug Administration (FDA) finds that an insulin is biosimilar to a reference product, the insulin shall be deemed interchangeable with the reference product. (A biological product is biosimilar to a reference product if the two products are highly similar and have no clinically meaningful differences; the reference product generally receives FDA approval first, but the biosimilar product is typically less expensive.)
Under current law, a biological product that is biosimilar to a reference product may be deemed interchangeable with the reference product only if it meets additional requirements. Current law provides that interchangeable products may be substituted for each other without the prescriber's involvement.

[Congressional Bills 116th Congress]
[From the U.S. Government Publishing Office]
[H.R. 8190 Introduced in House (IH)]

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116th CONGRESS
  2d Session
                                H. R. 8190

  To amend the Public Health Service Act to deem any insulin that is 
 determined by the Secretary to be biosimilar to the reference product 
    to be interchangeable with the reference product, and for other 
                               purposes.


_______________________________________________________________________


                    IN THE HOUSE OF REPRESENTATIVES

                           September 8, 2020

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

_______________________________________________________________________

                                 A BILL


 
  To amend the Public Health Service Act to deem any insulin that is 
 determined by the Secretary to be biosimilar to the reference product 
    to be interchangeable with the reference product, 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 ``Biosimilar Insulin Access Act of 
2020''.

SEC. 2. DEEMING BIOSIMILAR INSULIN TO BE INTERCHANGEABLE.

    (a) In General.--Section 351(k)(3) of the Public Health Service Act 
(42 U.S.C. 262(k)(3)) is amended by adding at the end the following:
                    ``(B) Biosimilar insulin.--
                            ``(i) Deemed interchangeable.--
                        Notwithstanding paragraph (4), an insulin is 
                        deemed to be interchangeable with the reference 
                        product if the insulin is determined by the 
                        Secretary to be biosimilar to the reference 
                        product.
                            ``(ii) Shortening exclusivity for first 
                        interchangeable product.--
                                    ``(I) Action instituted.--If an 
                                action is instituted under subsection 
                                (l)(6) against the applicant that 
                                submitted the application for an 
                                insulin that is the first approved 
                                interchangeable biosimilar biological 
                                product, paragraph (6) shall apply with 
                                respect to such insulin without regard 
                                to paragraph (6)(A).
                                    ``(II) Action not instituted.--If 
                                such an action is not instituted with 
                                respect to an insulin that is approved 
                                as an interchangeable biosimilar 
                                biological product, the Secretary shall 
                                make a determination on the 
                                interchangeability of any second or 
                                subsequent biological product without 
                                regard to the delay otherwise required 
                                by paragraph (6).
                            ``(iii) Applicability.--Clause (i) applies 
                        without regard to whether the insulin is 
                        determined to be biosimilar to the reference 
                        product, or deemed to be licensed pursuant to 
                        this section, before or after the date of 
                        enactment of the Biosimilar Insulin Access Act 
                        of 2020.''.
    (b) Conforming Changes.--Section 351(k)(3) of the Public Health 
Service Act (42 U.S.C. 262(k)(3)) is amended--
            (1) by striking ``Upon review'' and inserting the 
        following:
                    ``(A) In general.--Upon review'';
            (2) by striking ``(A) the Secretary'' and inserting the 
        following:
                            ``(i) the Secretary'';
            (3) by striking ``(i) is biosimilar'' and inserting the 
        following:
                                    ``(I) is biosimilar'';
            (4) by striking ``(ii) can be'' and inserting the 
        following:
                                    ``(II) can be''; and
            (5) by striking ``(B) the applicant'' and inserting the 
        following:
                            ``(ii) the applicant''.
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