(B) generic versions of biological products; 
and 
(C) the reference products. 
(2) The specific criteria that have been used by 
the Secretary to approve generic versions of nonbio-
logic complex drug products that have not been fully 
characterized or generic versions of biological prod-
ucts. 
(3) The specific criteria specified in guidances, 
draft guidance, and other documents issued by the 
Secretary regarding applications under section 
351(k) of the Public Health Service Act (42 U.S.C. 
262(k)) for the licensing of biosimilar biological 
products. 
(d) OPTIONAL CONSIDERATION.—In carrying out the 
study under subsection (a), the Comptroller General may 
under subsection (c) consider the following information 
from foreign countries: 
(1) Reports described in subsection (c)(1) from 
foreign countries that are listed in clause (i) or (ii) 
of section 802(b)(1)(A) of the Federal Food, Drug, 
and Cosmetic Act (21 U.S.C. 382(b)(1)(A)) or are 
designated pursuant to section 802(b)(1)(B) of such 
Act (21 U.S.C. 382(b)(1)(B)). 
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(2) The guidelines or recommendations of the 
pharmaceutical regulatory agencies of foreign coun-
tries described in paragraph (1) regarding any class 
of products that such an agency regulates as a bio-
similar biological product, but that has been or could 
be approved as a generic drug in the United States. 
(3) Any instance where the Secretary or such 
foreign regulatory agencies have, after approving a 
generic version (or a foreign equivalent) of a nonbio-
logic complex drug product that has not been fully 
characterized or a generic version (or a foreign 
equivalent) of a biological product, sought a clinical 
trial to confirm— 
(A) the generic version (or foreign equiva-
lent) is therapeutically equivalent to the ref-
erence product (or meets a similar standard, in 
the case of a foreign regulatory agency); or 
(B) the safety and effectiveness of the ge-
neric version (or foreign equivalent). 
(e) COMPLETION DATE.—Not later than the expira-
tion of the 2-year period beginning on the date of the en-
actment of this Act, the Comptroller General shall com-
plete the study under subsection (a) and submit a report 
describing the findings and conclusions of the study to the 
Secretary, the Committee on Energy and Commerce of the 
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House of Representatives, and the Committee on Health, 
Education, Labor, and Pensions of the Senate. 
(f) DEFINITIONS.— 
(1) COMPLEX
DRUG
PRODUCT
NOT
FULLY 
CHARACTERIZED.—For purposes of this section, the 
terms ‘‘complex drug product that has not been fully 
characterized’’ and ‘‘complex drug products that 
have not been fully characterized’’, with respect to a 
nonbiologic drug, means a drug for which— 
(A) the active ingredient has molecular di-
versity; 
(B) scientific analytic methodologies are 
unable to fully identify the molecular structures 
and physiochemical properties of the active in-
gredient; and 
(C) the nature of the active ingredient is 
not understood sufficiently to identity— 
(i) all the molecular components of 
the drug that are involved in producing the 
therapeutic effect; and 
(ii) the mechanisms of action that 
produce such effect. 
(2) OTHER DEFINITIONS.—For purposes of this 
section: 
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(A) The term ‘‘bioequivalent’’, with respect 
to a generic drug, has the meaning given such 
term in section 505(j)(8)(B) of the Federal 
Food, Drug, and Cosmetic Act (21 U.S.C. 
355(j)(8)(B)). 
(B) The term ‘‘generic drug’’ or ‘‘generic 
version’’, with respect to the United States, 
means a drug that is approved under section 
505(j) of the Federal Food, Drug, and Cos-
metic Act (21 U.S.C. 355(j)). 
(C) The term ‘‘generic drug application’’ 
means an abbreviated application for the ap-
proval of a new drug under section 505(j) of 
the Federal Food, Drug, and Cosmetic Act (21 
U.S.C. 355(j)). 
(D) The term ‘‘proposed’’, with respect to 
a generic version, means subject to a generic 
drug application that is pending before the 
Food and Drug Administration. 
(E) The term ‘‘reference product’’, with re-
spect to a generic drug, has the meaning given 
the term ‘‘listed drug’’ in section 505(j) of the 
Federal Food, Drug, and Cosmetic Act (21 
U.S.C. 355(j)). 
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(F) The term ‘‘Secretary’’ means the Sec-
retary of Health and Human Services. 
Æ 
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