116 HR 8190 IH: Biosimilar Insulin Access Act of 2020 U.S. House of Representatives 2020-09-08 text/xml EN Pursuant to Title 17 Section 105 of the United States Code, this file is not subject to copyright protection and is in the public domain.

I116th CONGRESS2d SessionH. R. 8190IN THE HOUSE OF REPRESENTATIVESSeptember 8, 2020Mr. Grothman introduced the following bill; which was referred to the Committee on Energy and CommerceA BILLTo 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.

1.

Short title

This Act may be cited as the Biosimilar Insulin Access Act of 2020.

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.