termining the safety, purity, and potency 
of the biological product has been identi-
fied after the testing has begun. 
‘‘(D) PROCEDURE
REGARDING
CERTAIN 
DECISIONS.—A decision under subparagraph 
(C)(ii) by the director shall be in writing and 
the Secretary shall provide to the sponsor or 
applicant an opportunity for a meeting at which 
the director and the sponsor or applicant will be 
present and at which the director will document 
the scientific issue involved. 
‘‘(E) EFFECT OF DECISIONS.—The written 
decisions of the reviewing division shall be bind-
ing upon, and may not directly or indirectly be 
changed by, the field or compliance office per-
sonnel unless such field or compliance office 
personnel demonstrate to the reviewing division 
why such decision should be modified. 
‘‘(F) DELAYS BY REVIEWING DIVISIONS.— 
No action by the reviewing division may be de-
layed because of the unavailability of informa-
tion from or action by field personnel unless the 
reviewing division determines that a delay is 
necessary to assure the marketing of a safe, 
pure, and potent biological product. 
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‘‘(4) APPROVAL
OF
COMPARABLE
OR
INTER-
CHANGEABLE BIOLOGICAL PRODUCTS.— 
‘‘(A) 
DETERMINATION
OF
COM-
PARABILITY.—Upon review of an application 
submitted under paragraph (1) or (2) for a bio-
logical product, the Secretary shall issue a com-
parable biological product license for all condi-
tions of use of the reference product sharing 
the same mechanism or mechanisms of action 
for which the applicant has demonstrated com-
parability for a single condition of use, or, if the 
mechanism or mechanisms of action are un-
known, for the condition or conditions of use 
for which the data submitted establishes com-
parability, unless the Secretary finds and in-
forms the applicant that— 
‘‘(i) information submitted in the ap-
plication or any other information available 
to the Secretary is insufficient to show 
that the biological product is comparable 
to the reference product for the condition 
or conditions of use prescribed, rec-
ommended, or suggested in the labeling 
proposed in the application; 
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‘‘(ii) information submitted in the ap-
plication or any other information available 
to the Secretary is insufficient to show 
that the biological product and the ref-
erence product contain highly similar prin-
cipal molecular structural features, not-
withstanding minor differences in hetero-
geneity profile, impurities, or degradation 
patterns; 
‘‘(iii) information submitted in the ap-
plication or any other information available 
to the Secretary is insufficient to show 
that the biological product and reference 
product utilize the same mechanism or 
mechanisms of action for the conditions of 
use prescribed, recommended, or suggested 
in the labeling proposed for the biological 
product, unless the mechanism or mecha-
nisms of action are not known for the ref-
erence product for such condition or condi-
tions; 
‘‘(iv) information submitted in the ap-
plication or any other information available 
to the Secretary is insufficient to show 
that the route of administration, the dos-
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age form, and the strength of the biological 
product are the same as those of the ref-
erence product; 
‘‘(v) information submitted in the ap-
plication or any other information available 
to the Secretary is insufficient to show 
that the condition or conditions of use pre-
scribed, recommended, or suggested in the 
labeling proposed for the biological product 
are limited to one or more of the same use 
or uses as have been previously approved 
for the reference product; 
‘‘(vi) information submitted in the ap-
plication or any other information available 
to the Secretary shows (I) the inactive in-
gredients of the biological product are un-
safe for use under the conditions pre-
scribed, recommended, or suggested in the 
labeling proposed for the biological prod-
uct, or (II) the composition of the biologi-
cal product is unsafe under such conditions 
because of the type or quantity of inactive 
ingredients included or the manner in 
which the inactive ingredients are included; 
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