biosimilar biological product application

(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 allergenic extract product; (III) an in vitro diagnostic biological product; or (IV) 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.

Source

21 USC § 379j-51(4)


Scoping language

For purposes of this subpart
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