biosimilar biological product application
Defined in 1 place of the United States Code.
(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.
Source
- 2012–202621 U.S.C. § 379j-51Food and Drugs · Definitions · for purposes of this subpart
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.
Source
- 2026–present21 U.S.C. § 379j-51Food and Drugs · Definitions · for purposes of this subpart