under paragraph (17)(C) against the 
applicant that submitted the applica-
tion for the first approved inter-
changeable 
comparable 
biological 
product; or 
‘‘(II) the dismissal with or with-
out prejudice of an action instituted 
under paragraph (17)(C) against the 
applicant that submitted the applica-
tion for the first approved inter-
changeable 
comparable 
biological 
product; or 
‘‘(iii)(I) 36 months after approval of 
the first interchangeable comparable bio-
logical product if the applicant has been 
sued under paragraph (17)(C) and such 
litigation is still ongoing within such 36- 
month period; or 
‘‘(II) one year after approval in the 
event that the first approved interchange-
able comparable applicant has not been 
sued under paragraph (17)(C). 
For purposes of this subparagraph, the term 
‘final court decision’ means a final decision of 
a court from which no appeal (other than a pe-
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tition to the United States Supreme Court for 
a writ of certiorari) has been or can be taken. 
‘‘(B) REBRANDED INTERCHANGEABLE BI-
OLOGICAL PRODUCT.—For purposes of this sub-
section, the term ‘rebranded interchangeable bi-
ological product’— 
‘‘(i) means any rebranded inter-
changeable version of the reference product 
involved that the holder of the biological 
product license approved under subsection 
(a) for that reference product seeks to 
commence marketing, selling, or distrib-
uting, directly or indirectly; and 
‘‘(ii) does not include any product to 
be marketed, sold, or distributed— 
‘‘(I) by an entity eligible for ex-
clusivity with respect to such product 
under this paragraph; or 
‘‘(II) after expiration of any ex-
clusivity with respect to such product 
under this paragraph. 
‘‘(11) HEARING.—If the Secretary decides to 
disapprove an abbreviated biological product applica-
tion, the Secretary shall give the applicant notice of 
an opportunity for a hearing before the Secretary on 
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the question of whether such application is approv-
able. If the applicant elects to accept the opportunity 
for hearing by written request within thirty days 
after such notice, such hearing shall commence not 
more than ninety days after the expiration of such 
thirty days unless the Secretary and the applicant 
otherwise agree. Any such hearing shall thereafter 
be conducted on an expedited basis, and the Sec-
retary’s order thereon shall be issued within ninety 
days after the date fixed by the Secretary for filing 
final briefs. 
‘‘(12) FINAL ACTION DATE.— 
‘‘(A) IN
GENERAL.—The Secretary shall 
take a final action on an abbreviated biological 
product application by the date that is 8 cal-
endar months following the sponsor’s submis-
sion of such application, or 180 days following 
the Secretary’s notification to the applicant that 
its application has been accepted for filing, 
whichever is earlier. 
‘‘(B) EXTENSION.—The final action date 
provided by subparagraph (A) with respect to 
an application may be extended for such period 
of time as is agreed to by the Secretary and the 
applicant in a jointly executed written agree-
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