I 
110TH CONGRESS 
1ST SESSION H. R. 1956 
To amend the Public Health Service Act to provide for the approval of 
similar biological products, and for other purposes. 
IN THE HOUSE OF REPRESENTATIVES 
APRIL 19, 2007 
Mr. INSLEE (for himself, Mr. GENE GREEN of Texas, and Ms. BALDWIN) in-
troduced the following bill; which was referred to the Committee on En-
ergy and Commerce 
A BILL 
To amend the Public Health Service Act to provide for 
the approval of similar 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. SHORT TITLE. 
This Act may be cited as the ‘‘Patient Protection and 
Innovative Biologic Medicines Act of 2007’’. 
SEC. 2. APPROVAL OF SIMILAR BIOLOGICAL PRODUCTS. 
(a) IN GENERAL.—Section 351 of the Public Health 
Service Act (42 U.S.C. 262) is amended— 
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(1) in subsection (j), by striking ‘‘under sub-
section (a)’’ and inserting ‘‘under subsection (a) or 
(k)’’; and 
(2) by adding at the end the following: 
‘‘(k) SIMILAR BIOLOGICAL PRODUCTS.— 
‘‘(1) APPLICATION.— 
‘‘(A) SUBMISSION.—Any person may sub-
mit an application under this subsection for ap-
proval of a biologics license for a biological 
product (in this section referred to as the ‘simi-
lar biological product’) that is claimed to be 
similar to a qualified biological product (in this 
subsection referred to as the ‘reference prod-
uct’). 
‘‘(B) DEFINITION.—In this subsection, the 
term ‘qualified biological product’ means a bio-
logical product that is a biotechnology-derived 
therapeutic biological product licensed under 
subsection (a) or a biotechnology-derived thera-
peutic protein product subject to an approved 
application that was submitted under section 
505(b)(1) of the Federal Food, Drug, and Cos-
metic Act. 
‘‘(2) REVIEW AND APPROVAL OF SIMILAR BIO-
LOGICAL PRODUCT APPLICATIONS.— 
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‘‘(A) REVIEW.—An application submitted 
under this subsection for a similar biological 
product shall be reviewed— 
‘‘(i) by the division that was respon-
sible for review and approval of the ref-
erence product; and 
‘‘(ii) in accordance with the proce-
dures for review of biologics license appli-
cations established by the Secretary pursu-
ant to subsection (a)(2)(A). 
‘‘(B) APPROVAL.—The Secretary shall ap-
prove the application submitted under para-
graph (1) only if— 
‘‘(i) the applicant demonstrates that 
the similar biological product conforms to 
the applicable final product-class specific 
guidance and, on the basis of the data sub-
mitted in conformance with such guidance, 
the Secretary concludes the product is 
safe, pure, and potent; 
‘‘(ii) the facility in which the similar 
biological product is manufactured, proc-
essed, packed, or held meets standards de-
signed to assure that the biological product 
continues to be safe, pure, and potent; and 
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‘‘(iii) the applicant (or other appro-
priate person) consents to the inspection of 
the facility that is the subject of the appli-
cation, in accordance with subsection (c). 
‘‘(C) CONDITIONS
OF
APPROVAL.—The 
Secretary may approve an application submitted 
under paragraph (1) for a similar biological 
product— 
‘‘(i) only for indications for which the 
reference product is approved; and 
‘‘(ii) only if, with respect to each such 
indication, the application conforms to the 
applicable final product-class specific guid-
ance, and on the basis of non-clinical and 
clinical data submitted regarding such in-
dication, the Secretary concludes the prod-
uct is safe, pure, and potent. 
‘‘(D) THERAPEUTIC
EQUIVALENCE.—The 
Secretary shall not designate a similar biologi-
cal product as therapeutically equivalent to the 
reference product. 
‘‘(3) TIME FRAMES FOR APPLICATION AND AU-
THORIZATION.— 
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‘‘(A) SUBMISSION OF APPLICATIONS.—No 
application for a similar biological product may 
be submitted under this subsection unless— 
‘‘(i) the Secretary has published under 
paragraph (5) final product-class specific 
guidance applicable to the reference prod-
uct; and 
‘‘(ii) not less than 12 years have 
elapsed from the date on which the ref-
erence product was approved or licensed. 
‘‘(B) EFFECTIVE
DATE
OF
APPROVAL.— 
Subject to subparagraph (C), approval of an 
application submitted under paragraph (1) shall 
not be made effective until at least 14 years 
have elapsed from the date on which the ref-
erence product was approved or licensed. 
‘‘(C) SIGNIFICANT
CLINICAL
BENEFIT.— 
Approval of an application submitted under 
paragraph (1) shall not be made effective until 
at least 15 years have elapsed from the date on 
which the reference product was approved or li-
censed if— 
‘‘(i) during the 12-year period fol-
lowing the approval or licensing of the ref-
erence product, the Secretary approves a 
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