‘‘(iv) data from comparative nonclin-
ical studies demonstrating that the similar 
biological product and the reference prod-
uct have similar profiles in terms of phar-
macokinetics, pharmacodynamics, toxicity, 
immunogenicity, and other relevant fac-
tors; 
‘‘(v) data from comparative clinical 
trials demonstrating that the similar bio-
logical product and the reference product 
have similar profiles in terms of safety, pu-
rity, and potency, including pharmaco-
kinetic studies, pharmacodynamic studies, 
and trials of sufficient size and duration to 
demonstrate that the products are similar 
in their safety (in terms of nature, serious-
ness, and frequency of adverse reactions), 
purity, and potency profiles; and 
‘‘(vi) a plan for postmarketing safety 
monitoring 
(in 
addition 
to 
ordinary 
pharmacovigilance), including with respect 
to clinical trials; antibody testing and, as 
appropriate, other tests to investigate 
immunogenicity; patient registries; and 
other surveillance measures to monitor the 
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clinical safety and risk-benefit balance of 
the similar biological product. 
‘‘(6) REVISIONS TO GUIDANCE.—If a new con-
dition of use is approved for a reference product 
after the latest publication of the final product-class 
specific guidance applicable to such product, the 
Secretary shall promptly update and republish the 
guidance in accordance with paragraphs (4) and (5) 
(irrespective of whether a request for such revision 
has been received under paragraph (4)(A)) to ad-
dress the data and information that will be required 
in an application under this subsection for approval 
of the new condition of use. The requirements of 
paragraph (2)(C) shall apply if the new condition of 
use is a new indication. 
‘‘(7) SIMILAR BIOLOGICAL PRODUCTS ADVISORY 
COMMITTEE.— 
‘‘(A) 
ESTABLISHMENT.—The 
Secretary 
shall establish a Similar Biological Products 
Advisory Committee (in this paragraph referred 
to as the ‘Committee’). 
‘‘(B) DUTIES.—The Committee shall— 
‘‘(i) provide expert scientific advice 
and recommendations to the Secretary re-
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garding the development and approval of 
similar biological products; and 
‘‘(ii) in formulating such advice and 
recommendations, provide interested per-
sons with a reasonable opportunity to 
make written and oral presentations. 
‘‘(C) MEMBERSHIP.— 
‘‘(i) QUALIFICATIONS.—The Secretary 
shall appoint to serve on the Committee in-
dividuals with expertise on therapeutic bio-
logical products, including manufacturing, 
safety, effectiveness, and other relevant 
matters. The Secretary shall ensure that 
the Committee consists of members with 
adequately diversified expertise and prac-
tical experience in such fields as clinical 
medicine, biological and physical sciences, 
pharmacoepidemiology 
and 
postmarket 
safety surveillance, and related professions. 
‘‘(ii) NOMINATIONS.—In appointing 
members of the Committee, the Secretary 
shall provide an opportunity for scientific, 
industry, and consumer organizations and 
the public to nominate such members. 
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‘‘(iii) 
NONVOTING
MEMBERS.—The 
Committee shall include, as nonvoting 
members, representatives of patient organi-
zations, manufacturers of innovative bio-
logical products, and manufacturers of 
similar biological products. 
‘‘(iv) 
SUPPLEMENTAL
MEMBER-
SHIP.—For the purpose of developing 
product-class specific guidance under para-
graphs (4) and (5), the Secretary may sup-
plement the membership of the Committee, 
or arrange for advice from another advi-
sory committee, in order to obtain the ad-
vice of individuals with special expertise re-
lating to any product under review. 
‘‘(l) PROPER NAME.—For purposes of this section: 
‘‘(1) BIOTECHNOLOGY-DERIVED
THERAPEUTIC 
PROTEINS.— 
‘‘(A) IN
GENERAL.—Subject to subpara-
graph (D), the term ‘proper name’, with respect 
to a biotechnology-derived therapeutic protein, 
means— 
‘‘(i) the name adopted for such pro-
tein by the United States Adopted Names 
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Council if such name is a unique USAN; 
or 
‘‘(ii) 
if 
the 
biotechnology-derived 
therapeutic protein lacks a unique USAN, 
an official name designated pursuant to 
subparagraph (C). 
‘‘(B) UNIQUE
USAN.—The term ‘unique 
USAN’, with respect to a biotechnology-derived 
therapeutic protein, means a name adopted for 
such protein by the United States Adopted 
Names Council that has not been adopted for 
any protein manufactured by a different person. 
‘‘(C) DESIGNATION.—The Secretary shall 
designate an official name for any bio-
technology-derived 
therapeutic 
protein 
that 
lacks a unique USAN. Any official name des-
ignated under this subparagraph shall be the 
only official name of that protein used in any 
official compendium published after such name 
has been designated. In no event, however, shall 
the Secretary designate an official name so as 
to infringe a valid trademark. Any designation 
under this subparagraph shall be made by rule 
in accordance with section 553 of title 5, 
United States Code. 
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‘‘(D) 
EXCEPTION.—The 
term 
‘proper 
name’, with respect to a biotechnology-derived 
therapeutic protein that was licensed by the 
Secretary prior to the effective date of the Pa-
tient Protection and Innovative Biologic Medi-
cines Act of 2007, means the name adopted for 
such protein by the United States Adopted 
Names Council, irrespective of whether such 
name is a unique USAN. 
‘‘(2) OTHER
BIOLOGICAL
PRODUCTS.—The 
term ‘proper name’, with respect to a biological 
product that is not a biotechnology-derived thera-
peutic protein, means— 
‘‘(A) the official name designated by the 
Secretary for such biological product pursuant 
to section 508 of the Federal Food, Drug, and 
Cosmetic Act; 
‘‘(B) if there is no such official name and 
such biological product is an article recognized 
in an official compendium, the official title 
thereof in such compendium; or 
‘‘(C) if neither subparagraph (A) nor sub-
paragraph (B) applies, the common or usual 
name, if any, of such biological product.’’. 
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