supplement to the new drug or biologics li-
cense application for the reference product 
that seeks approval to market the ref-
erence product for a new indication; and 
‘‘(ii) in the opinion of the Secretary, 
the new indication provides a significant 
clinical benefit in comparison with existing 
therapies. 
‘‘(D) EXCLUSIVE APPROVAL PATHWAY.— 
The Secretary may not approve, under any 
other provision of law, a product that is claimed 
to be similar to or the same as a reference 
product. 
‘‘(4) REQUESTS FOR ISSUANCE OF PRODUCT- 
CLASS SPECIFIC GUIDANCE.— 
‘‘(A) IN GENERAL.—Any person may sub-
mit a request to the Secretary for the issuance 
of product-class specific guidance applicable to 
a qualified biological product and its class. 
‘‘(B) PRIORITY.—The Secretary— 
‘‘(i) in prioritizing among requests 
under this paragraph for guidance, shall 
consider likely market entry dates of simi-
lar biological products and the amount of 
time that will be needed to prepare the re-
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quested product-class specific guidance; 
and 
‘‘(ii) may summarily reject frivolous 
or unsupported requests. 
‘‘(C) ISSUANCE
OF
GUIDANCE.—In re-
sponse to a request under this paragraph, the 
Secretary shall— 
‘‘(i) publish in the Federal Register a 
concept paper setting forth the specific 
questions to be addressed in product-class 
specific guidance and invite comments on 
the concept paper from any interested per-
sons; 
‘‘(ii) accept comments on the concept 
paper for not less than 4 months; 
‘‘(iii) consider the public comments on 
the concept paper; 
‘‘(iv) publish in the Federal Register 
proposed product-class specific guidance 
and invite comments on the proposed guid-
ance from any interested persons; 
‘‘(v) accept comments on the proposed 
guidance for not less than 6 months; 
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‘‘(vi) obtain the advice of the Similar 
Biological Products Advisory Committee 
with respect to the proposed guidance; and 
‘‘(vii) except as provided in subpara-
graph (D), not later than 24 months after 
receipt of the initial request, publish in the 
Federal Register final product-class spe-
cific guidance or a determination that, 
given the current state of scientific and 
technical knowledge, it is not possible to 
issue product-class specific guidance set-
ting forth data that will ensure the safety, 
purity, and potency of similar biological 
products to be covered by the guidance. 
‘‘(D) CONSOLIDATION OF REQUESTS.—The 
Secretary may consolidate requests submitted 
under this paragraph that refer to closely re-
lated products or product classes. If the Sec-
retary chooses to consolidate such requests, the 
Secretary shall publish final product-class spe-
cific guidance or a determination described in 
subparagraph (C)(vii) not later than 30 months 
after receipt of the first request for guidance 
for any product in the class. 
‘‘(5) PRODUCT-CLASS SPECIFIC GUIDANCE.— 
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‘‘(A) IN
GENERAL.—Guidance published 
under paragraph (4) shall describe the data and 
information that will be required in an applica-
tion submitted under paragraph (1). 
‘‘(B) REQUIRED
ELEMENTS.—At a min-
imum, guidance published under paragraph (4) 
shall require— 
‘‘(i) data demonstrating the consist-
ency and robustness of the manufacturing 
process for an active ingredient of the 
similar biological product and the finished 
formulation of the similar biological prod-
uct; 
‘‘(ii) data demonstrating the stability, 
compatibility (such as with excipients), and 
biological and physicochemical integrity of 
the active ingredient of the similar biologi-
cal product; 
‘‘(iii) data from physical, chemical, 
and biological assays fully characterizing 
the similar biological product, in compari-
son with the reference product, at both the 
active ingredient and finished product lev-
els; 
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