biosimilar biological product
Defined in 3 places across 2 titles of the United States Code.
In this subsection, the term “biosimilar biological product” has the meaning given such term in section 1395w–3a(c)(6) of this title.
Source
- 2022–present42 U.S.C. § 1320f-1The Public Health and Welfare · Selection of negotiation-eligible drugs as selected drugs · in this section
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.
Source
- 2010–present42 U.S.C. § 1395WThe Public Health and Welfare · Use of average sales price payment methodology · under this section
The term “biosimilar biological product” means a product for which a biosimilar biological product application has been approved.
Source
- 2012–201721 U.S.C. § 379j-51Food and Drugs · Definitions · for purposes of this subpart
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.
Source
- 2017–present21 U.S.C. § 379j-51Food and Drugs · Definitions · for purposes of this subpart