biosimilar biological product establishment
Defined in 1 place of the United States Code.
(A) The term “biosimilar biological product establishment” means a foreign or domestic place of business—
(i) that is at one general physical location consisting of one or more buildings, all of which are within 5 miles of each other; and
(ii) at which one or more biosimilar biological products are manufactured in final dosage form.
(B) For purposes of subparagraph (A)(ii), the term “manufactured” does not include packaging.
Source
- 2012–202621 U.S.C. § 379j-51Food and Drugs · Definitions · for purposes of this subpart
The term “biosimilar biological product establishment” means a foreign or domestic place of business—
(i) that is at one general physical location consisting of one or more buildings, all of which are within 5 miles of each other; and
(ii) at which one or more biosimilar biological products are manufactured in final dosage form.
Source
- 2026–present21 U.S.C. § 379j-51Food and Drugs · Definitions · for purposes of this subpart