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21 U.S. Code § 379j-51. Definitions
For purposes of this subpart:(1)
The term “adjustment factor” applicable to a fiscal year is the Consumer Price Index for urban consumers (Washington-Arlington-Alexandria, DC–VA–MD–WV; Not Seasonally Adjusted; All items) for September of the preceding fiscal year divided by such Index for September 2011.
(2) The term “affiliate” means a business entity that has a relationship with a second business entity if, directly or indirectly—
(A)
one business entity controls, or has the power to control, the other business entity; or
(B)
a third party controls, or has power to control, both of the business entities.
(3)
The term “biosimilar biological product” means a specific strength of a biological product in final dosage form for which a biosimilar biological product application has been approved.
(4)
(A)
Subject to subparagraph (B), the term “biosimilar biological product application” means an application for licensure of a biological product under section 262(k) of title 42.
(B) Such term does not include—
(i)
a supplement to such an application;
(ii)
an application filed under section 262(k) of title 42 that cites as the reference product a bovine blood product for topical application licensed before September 1, 1992, or a large volume parenteral drug product approved before such date;
(iii) an application filed under section 262(k) of title 42 with respect to—
(I)
whole blood or a blood component for transfusion;
(II)
an in vitro diagnostic biological product; or
(III)
a biological product for further manufacturing use only; or
(iv)
an application for licensure under section 262(k) of title 42 that is submitted by a State or Federal Government entity for a product that is not distributed commercially.