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-
tives of the United States of America in Congress assembled, 
SECTION 1. STREAMLINING THE TRANSITION OF BIOLOGI-
CAL PRODUCTS. 
(a) CONTINUED REVIEW
OF CERTAIN APPLICA-
TIONS.—Section 7002(e)(4)(B) of the Biologics Price 
Competition and Innovation Act of 2009 (Public Law 
111–148) is amended— 
(1) by striking clauses (i), (ii), and (vi); and 
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(2) by inserting before clause (iii) the following: 
‘‘(i) IN GENERAL.—With respect to an 
application for a biological product sub-
mitted under subsection (b) or (j) of sec-
tion 505 of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 355) that is filed 
not later than March 23, 2019, and that is 
pending (or tentatively approved) as of 
March 23, 2020— 
‘‘(I) the Secretary shall continue 
to review such application under such 
section 505, even if such review con-
tinues after March 23, 2020; and 
‘‘(II) upon approval of such ap-
plication, such application shall be 
deemed to be a license for the biologi-
cal product under section 351 of the 
Public Health Service Act, pursuant 
to subparagraph (A), and any period 
of exclusivity, as applicable, shall be 
determined in accordance with such 
section. 
‘‘(ii) 
TREATMENT
OF
LISTED 
DRUGS.—With respect to a drug that is a 
biological product that has been deemed li-
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censed under section 351 of the Public 
Health Service Act (42 U.S.C. 262) pursu-
ant to subparagraph (A) and that is ref-
erenced in an application described in 
clause (i), such drug shall— 
‘‘(I) continue to be identified as a 
listed drug on the list published pur-
suant to section 505(j)(7) of the Fed-
eral Food, Drug, and Cosmetic Act, 
and the information for such drug on 
such list shall not be revised (or re-
moved) unless and until the date on 
which each application described in 
clause (i) that references such drug 
is— 
‘‘(aa) no longer pending re-
view (or the approval of such 
drug is tentative) under section 
505 of the Federal Food, Drug, 
and Cosmetic Act (21 U.S.C. 
355); or 
‘‘(bb) removed from such list 
in accordance with subparagraph 
(C) of such section 505(j)(7); 
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‘‘(II) be subject only to require-
ments applicable to biological products 
licensed under section 351 of the Pub-
lic Health Service Act (42 U.S.C. 
262); and 
‘‘(III) be deemed to be a ref-
erence product under such section 351 
on the date on which the last applica-
tion described in clause (i) that ref-
erences such drug is no longer pend-
ing review (or tentatively approved) 
under section 505 of the Federal 
Food, Drug, and Cosmetic Act (21 
U.S.C. 355).’’. 
(b) CERTAIN INSULIN PRODUCTS DEEMED INTER-
CHANGEABLE BIOSIMILARS.—Section 7002(e)(4) of the 
Biologics Price Competition and Innovation Act of 2009 
(Public Law 111–148) is amended by adding at the end 
the following: 
‘‘(C) 
CERTAIN
INSULIN
PRODUCTS 
DEEMED INTERCHANGEABLE BIOSIMILARS.— 
‘‘(i) IN
GENERAL.—In carrying out 
subparagraph (A), a covered insulin prod-
uct shall be deemed to be an interchange-
able biosimilar biological product licensed 
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under section 351(k) of the Public Health 
Service Act. 
‘‘(ii) DEFINITIONS.—In this subpara-
graph: 
‘‘(I) The terms ‘biosimilar’ and 
‘interchangeable’ have the meaning 
given such terms in section 351(i) of 
the Public Health Service Act. 
‘‘(II) The term ‘covered insulin 
product’ means a biological product 
(including a chemically synthesized 
polypeptide) that is— 
‘‘(aa) an insulin product; 
and 
‘‘(bb) approved under sec-
tion 505 of the Federal Food, 
Drug, and Cosmetic Act pursu-
ant to an application submitted 
under subsection (b)(2) of such 
section.’’. 
Æ 
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