biosimilar biological product establishment
(7) (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.