I 

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. 

1 Be it enacted by the Senate and House of Representa2 tives of the United States of America in Congress assembled, 

3 SECTION 1. SHORT TITLE. 

4 This Act may be cited as the ‘‘Biosimilar Insulin Ac5 cess Act of 2020’’. 


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1 SEC. 2. DEEMING BIOSIMILAR INSULIN TO BE INTER2 CHANGEABLE. 

3 (a) IN GENERAL.—Section 351(k)(3) of the Public 

4 Health Service Act (42 U.S.C. 262(k)(3)) is amended by 

5 adding at the end the following: 

6 ‘‘(B) BIOSIMILAR INSULIN.— 

7 ‘‘(i) DEEMED INTERCHANGEABLE.— 

8 Notwithstanding paragraph (4), an insulin 

9 is deemed to be interchangeable with the 

10 reference product if the insulin is deter11 mined by the Secretary to be biosimilar to 

12 the reference product. 

13 ‘‘(ii) SHORTENING EXCLUSIVITY FOR

14 FIRST INTERCHANGEABLE PRODUCT.— 

15 ‘‘(I) ACTION INSTITUTED.—If an 

16 action is instituted under subsection 

17 (l)(6) against the applicant that sub18 mitted the application for an insulin 

19 that is the first approved interchange20 able biosimilar biological product, 

21 paragraph (6) shall apply with respect 

22 to such insulin without regard to 

23 paragraph (6)(A). 

24 ‘‘(II) ACTION NOT INSTI25 TUTED.—If such an action is not in26 stituted with respect to an insulin 


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1 that is approved as an interchangeable 

2 biosimilar biological product, the Sec3 retary shall make a determination on 

4 the interchangeability of any second 

5 or subsequent biological product with6 out regard to the delay otherwise re7 quired by paragraph (6). 

8 ‘‘(iii) APPLICABILITY.—Clause (i) ap9 plies without regard to whether the insulin 

10 is determined to be biosimilar to the ref11 erence product, or deemed to be licensed 

12 pursuant to this section, before or after the 

13 date of enactment of the Biosimilar Insulin 

14 Access Act of 2020.’’. 

15 (b) CONFORMING CHANGES.—Section 351(k)(3) of 

16 the Public Health Service Act (42 U.S.C. 262(k)(3)) is 

17 amended— 

18 (1) by striking ‘‘Upon review’’ and inserting the 

19 following: 

20 ‘‘(A) IN GENERAL.—Upon review’’; 

21 (2) by striking ‘‘(A) the Secretary’’ and insert22 ing the following: 

23 ‘‘(i) the Secretary’’; 

24 (3) by striking ‘‘(i) is biosimilar’’ and inserting 

25 the following: 


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1 ‘‘(I) is biosimilar’’; 

2 (4) by striking ‘‘(ii) can be’’ and inserting the 

3 following: 

4 ‘‘(II) can be’’; and 

5 (5) by striking ‘‘(B) the applicant’’ and insert6 ing the following: 

7 ‘‘(ii) the applicant’’. 

Æ 


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