To amend the Biologics Price Competition and Innovation Act of 2009 to make improvements with respect to the transition of biological products, and for other purposes.

I 116TH CONGRESS 2D SESSION H. R. 6155 To amend the Biologics Price Competition and Innovation Act of 2009 to make improvements with respect to the transition of biological products, and for other purposes. IN THE HOUSE OF REPRESENTATIVES MARCH 9, 2020 Mr. GROTHMAN introduced the following bill; which was referred to the Committee on Energy and Commerce A BILL To amend the Biologics Price Competition and Innovation Act of 2009 to make improvements with respect to the transition of biological products, and for other purposes. Be it enacted by the Senate and House of Representa- 1 tives of the United States of America in Congress assembled, 2 SECTION 1. STREAMLINING THE TRANSITION OF BIOLOGI- 3 CAL PRODUCTS. 4 (a) CONTINUED REVIEW OF CERTAIN APPLICA- 5 TIONS.—Section 7002(e)(4)(B) of the Biologics Price 6 Competition and Innovation Act of 2009 (Public Law 7 111–148) is amended— 8 (1) by striking clauses (i), (ii), and (vi); and 9 VerDate Sep 11 2014 02:54 Mar 14, 2020 Jkt 099200 PO 00000 Frm 00001 Fmt 6652 Sfmt 6201 E:\BILLS\H6155.IH H6155 kjohnson on DSK79L0C42PROD with BILLS 2 •HR 6155 IH (2) by inserting before clause (iii) the following: 1 ‘‘(i) IN GENERAL.—With respect to an 2 application for a biological product sub- 3 mitted under subsection (b) or (j) of sec- 4 tion 505 of the Federal Food, Drug, and 5 Cosmetic Act (21 U.S.C. 355) that is filed 6 not later than March 23, 2019, and that is 7 pending (or tentatively approved) as of 8 March 23, 2020— 9 ‘‘(I) the Secretary shall continue 10 to review such application under such 11 section 505, even if such review con- 12 tinues after March 23, 2020; and 13 ‘‘(II) upon approval of such ap- 14 plication, such application shall be 15 deemed to be a license for the biologi- 16 cal product under section 351 of the 17 Public Health Service Act, pursuant 18 to subparagraph (A), and any period 19 of exclusivity, as applicable, shall be 20 determined in accordance with such 21 section. 22 ‘‘(ii) TREATMENT OF LISTED 23 DRUGS.—With respect to a drug that is a 24 biological product that has been deemed li- 25 VerDate Sep 11 2014 02:54 Mar 14, 2020 Jkt 099200 PO 00000 Frm 00002 Fmt 6652 Sfmt 6201 E:\BILLS\H6155.IH H6155 kjohnson on DSK79L0C42PROD with BILLS 3 •HR 6155 IH censed under section 351 of the Public 1 Health Service Act (42 U.S.C. 262) pursu- 2 ant to subparagraph (A) and that is ref- 3 erenced in an application described in 4 clause (i), such drug shall— 5 ‘‘(I) continue to be identified as a 6 listed drug on the list published pur- 7 suant to section 505(j)(7) of the Fed- 8 eral Food, Drug, and Cosmetic Act, 9 and the information for such drug on 10 such list shall not be revised (or re- 11 moved) unless and until the date on 12 which each application described in 13 clause (i) that references such drug 14 is— 15 ‘‘(aa) no longer pending re- 16 view (or the approval of such 17 drug is tentative) under section 18 505 of the Federal Food, Drug, 19 and Cosmetic Act (21 U.S.C. 20 355); or 21 ‘‘(bb) removed from such list 22 in accordance with subparagraph 23 (C) of such section 505(j)(7); 24 VerDate Sep 11 2014 02:54 Mar 14, 2020 Jkt 099200 PO 00000 Frm 00003 Fmt 6652 Sfmt 6201 E:\BILLS\H6155.IH H6155 kjohnson on DSK79L0C42PROD with BILLS 4 •HR 6155 IH ‘‘(II) be subject only to require- 1 ments applicable to biological products 2 licensed under section 351 of the Pub- 3 lic Health Service Act (42 U.S.C. 4 262); and 5 ‘‘(III) be deemed to be a ref- 6 erence product under such section 351 7 on the date on which the last applica- 8 tion described in clause (i) that ref- 9 erences such drug is no longer pend- 10 ing review (or tentatively approved) 11 under section 505 of the Federal 12 Food, Drug, and Cosmetic Act (21 13 U.S.C. 355).’’. 14 (b) CERTAIN INSULIN PRODUCTS DEEMED INTER- 15 CHANGEABLE BIOSIMILARS.—Section 7002(e)(4) of the 16 Biologics Price Competition and Innovation Act of 2009 17 (Public Law 111–148) is amended by adding at the end 18 the following: 19 ‘‘(C) CERTAIN INSULIN PRODUCTS 20 DEEMED INTERCHANGEABLE BIOSIMILARS.— 21 ‘‘(i) IN GENERAL.—In carrying out 22 subparagraph (A), a covered insulin prod- 23 uct shall be deemed to be an interchange- 24 able biosimilar biological product licensed 25 VerDate Sep 11 2014 02:54 Mar 14, 2020 Jkt 099200 PO 00000 Frm 00004 Fmt 6652 Sfmt 6201 E:\BILLS\H6155.IH H6155 kjohnson on DSK79L0C42PROD with BILLS 5 •HR 6155 IH under section 351(k) of the Public Health 1 Service Act. 2 ‘‘(ii) DEFINITIONS.—In this subpara- 3 graph: 4 ‘‘(I) The terms ‘biosimilar’ and 5 ‘interchangeable’ have the meaning 6 given such terms in section 351(i) of 7 the Public Health Service Act. 8 ‘‘(II) The term ‘covered insulin 9 product’ means a biological product 10 (including a chemically synthesized 11 polypeptide) that is— 12 ‘‘(aa) an insulin product; 13 and 14 ‘‘(bb) approved under sec- 15 tion 505 of the Federal Food, 16 Drug, and Cosmetic Act pursu- 17 ant to an application submitted 18 under subsection (b)(2) of such 19 section.’’. 20 Æ VerDate Sep 11 2014 02:54 Mar 14, 2020 Jkt 099200 PO 00000 Frm 00005 Fmt 6652 Sfmt 6301 E:\BILLS\H6155.IH H6155 kjohnson on DSK79L0C42PROD with BILLS