uct until the exclusivity period under para-
graph (10) has expired. 
‘‘(5) POSTMARKETING STUDIES FOR APPLICA-
TIONS SUBMITTED UNDER PARAGRAPH (1).—If the 
Secretary has agreed with the sponsor of the ref-
erence product, at the time of approval or any time 
thereafter, that the sponsor shall conduct one or 
more postmarketing safety studies, a person submit-
ting an application for a biological product under 
paragraph (1) may agree with the Secretary to con-
duct a similar postmarketing safety study or studies 
upon a reasonable showing that such study or stud-
ies would provide relevant information not available 
from the studies on the reference product. The Sec-
retary shall not, as a condition of approval, propose 
any additional postmarketing studies for such bio-
logical product. 
‘‘(6) DESIGNATION
OF
OFFICIAL
NAME.—If, 
pursuant to section 508 of the Federal Food, Drug, 
and Cosmetic Act, the Secretary determines that 
designation of an official name for a comparable bio-
logical product is necessary or desirable in the inter-
ests of usefulness or simplicity, the Secretary shall 
designate the same official name for the comparable 
biological product as the Secretary designated for 
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the reference product. This paragraph shall not 
apply to products approved under paragraph (7). 
‘‘(7) OTHER APPROVAL PROVISIONS.—The Sec-
retary shall approve, under the provisions of para-
graph (4)(A), an application for a license submitted 
under paragraph (2), except that the Secretary shall 
approve such an application that would otherwise be 
disapproved by reason of one or more of subpara-
graphs (A) through (E) of paragraph (4)(A), if the 
application and any other information available to 
the Secretary are sufficient to establish the safety, 
purity, and potency of the comparable biological 
product relative to the reference product for the pro-
posed condition or conditions of use for such prod-
uct. 
‘‘(8) ESTABLISHING INTERCHANGEABILITY FOR 
COMPARABLE BIOLOGICAL PRODUCTS.— 
‘‘(A) IN GENERAL.—In an original applica-
tion or a supplement to an application under 
this subsection, an applicant may submit infor-
mation to the Secretary to demonstrate the 
interchangeability of a comparable biological 
product and the reference product. An applicant 
may withdraw an interchangeability submission 
at any time. A request for an interchangeability 
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determination submitted after the filing of an 
application shall be considered a major amend-
ment to the application. Nothing in this sub-
section shall be construed to prohibit the Sec-
retary from making a determination of inter-
changeability at any time after approval. 
‘‘(B) GUIDANCE.—Within one year after 
enactment of the Access to Life-Saving Medi-
cine Act, the Secretary shall issue guidance re-
garding standards and requirements for inter-
changeability. The Secretary may make deter-
minations of interchangeability under para-
graph (4)(B) prior to issuing guidance under 
this subparagraph. 
‘‘(9) INTERCHANGEABILITY
LABELING
FOR 
COMPARABLE BIOLOGICAL PRODUCTS.—Upon a de-
termination of interchangeability, the Secretary, if 
requested by the applicant, shall provide for the 
label of the comparable biological product to include 
a statement that the biological product is inter-
changeable with the reference product for the condi-
tions of use prescribed, recommended, or suggested 
in the labeling for which interchangeability has been 
established. 
‘‘(10) EXCLUSIVITY.— 
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‘‘(A) IN GENERAL.—Upon review of an ab-
breviated biological product application relying 
on the same reference product for which a prior 
biological product has received a determination 
of interchangeability for any condition of use, 
the Secretary shall not make a determination 
under paragraph (4)(B) that the second or sub-
sequent biological product is interchangeable for 
any condition of use, and no holder of a biologi-
cal product license approved under subsection 
(a) shall manufacture, market, sell, or dis-
tribute a rebranded interchangeable biological 
product, directly or indirectly, or authorize any 
other person to manufacture, market, sell, or 
distribute a rebranded interchangeable biologi-
cal product, for any condition of use, until the 
earlier of— 
‘‘(i) 180 days after the first commer-
cial marketing of the first interchangeable 
comparable biological product to be ap-
proved as interchangeable for that ref-
erence product; 
‘‘(ii) one year after— 
‘‘(I) a final court decision on all 
patents in suit in an action instituted 
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