biosimilar biological product
Defined in 1 dictionary — U.S. Code
United States Code
21 U.S.C. § 379j-51 — for purposes of this subpart (2 versions over time)
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.
42 U.S.C. § 1395W — under this section (13 versions over time)
The term "biosimilar biological product" means a biological product approved under an abbreviated application for a license of a biological product that relies in part on data or information in an application for another biological product licensed under section 262 of this title.
42 U.S.C. § 1320f-1 — in this section (2 versions over time)
In this subsection, the term “biosimilar biological product” has the meaning given such term in section 1395w–3a(c)(6) of this title.