‘‘(A) approves the application; or 
‘‘(B) disapproves the application and sets 
forth in detail an enumeration of the specific 
deficiencies in the particular application and of 
the specific, enumerated actions the sponsor 
would be required to take in order for the spon-
sor to receive a final action letter that approves 
such application. 
‘‘(8) The term ‘final action date’ means, with 
respect to an abbreviated biological product applica-
tion, the date by which the Secretary must take a 
final action on the application pursuant to sub-
section (k)(11). 
‘‘(9) The term ‘reviewing division’ means the 
division responsible for the review of an application 
for approval of a biological product (including all sci-
entific and medical matters, chemistry, manufac-
turing, and controls).’’. 
(b) RULE OF CONSTRUCTION.—Nothing in this Act 
or the amendments made by this Act shall be construed 
to exclude an application for licensure of a biological prod-
uct under section 351(k) from the definition of a human 
drug application in section 735(1)(C) of the Federal Food, 
Drug, and Cosmetic Act (21 U.S.C. 379g(1)(C)). 
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SEC. 3. REGULATION OF COMPARABLE AND INTERCHANGE-
ABLE BIOLOGICAL PRODUCTS. 
(a) IN GENERAL.—Section 351 of the Public Health 
Service Act (42 U.S.C. 262) is amended— 
(1) in subsection (a)(1)(A), by inserting ‘‘under 
this subsection or subsection (k)’’ after ‘‘biologics li-
cense’’; and 
(2) by adding at the end the following sub-
section: 
‘‘(k) REGULATION
OF COMPARABLE
AND INTER-
CHANGEABLE BIOLOGICAL PRODUCTS.— 
‘‘(1) SUBMISSION
OF
AN
ABBREVIATED
BIO-
LOGICAL PRODUCT APPLICATION.—Any person may 
file with the Secretary an abbreviated biological 
product application. Any such application shall in-
clude the following: 
‘‘(A) Data demonstrating that the biologi-
cal product is comparable to or interchangeable 
with the reference product. 
‘‘(B) Data demonstrating that the biologi-
cal product and reference product contain high-
ly similar principal molecular structural fea-
tures, notwithstanding minor differences in het-
erogeneity profile, impurities, or degradation 
patterns. The Secretary shall find the following 
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types of products to contain highly similar prin-
cipal molecular structural features: 
‘‘(i) Two protein biological products 
with differences in structure between them 
solely due to post-translational events, infi-
delity of translation or transcription, or 
minor differences in amino acid sequence. 
‘‘(ii) Two polysaccharide biological 
products with similar saccharide repeating 
units, even if the number of units differ 
and even if there are differences in post- 
polymerization modifications. 
‘‘(iii) Two glycosylated protein prod-
ucts with differences in structure between 
them 
solely 
due 
to 
post-translational 
events, infidelity of translation or tran-
scription, or minor differences in amino 
acid sequence, and if they had similar sac-
charide repeating units, even if the number 
of units differ and even if there were dif-
ferences in post-polymerization modifica-
tions. 
‘‘(iv) Two polynucleotide biological 
products with identical sequence of purine 
and pyrimidine bases (or their derivatives) 
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bound to an identical sugar backbone (ri-
bose, deoxyribose, or modifications of these 
sugars). 
‘‘(v) Closely related, complex partly 
definable biological products with similar 
therapeutic intent, such as two live viral 
products for the same indication. 
Two biological products not enumerated in the 
foregoing clauses may be demonstrated to con-
tain highly similar principal molecular struc-
tural features based upon such data and other 
information characterizing the two products as 
the Secretary determines to be necessary. 
‘‘(C) Data demonstrating that the biologi-
cal product and reference product utilize the 
same mechanism or mechanisms of action for 
the condition or conditions of use prescribed, 
recommended, or suggested in the proposed la-
beling, but only to the extent the mechanism or 
mechanisms of action are known for the ref-
erence product. 
‘‘(D) Information to show that the condi-
tion or conditions of use prescribed, rec-
ommended, or suggested in the labeling pro-
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