biosimilar biological product establishment
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 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.