small business
(3) Small business defined In this subsection, the term “small business” means an entity that has fewer than 500 employees, including employees of affiliates, and does not have a drug product that has been approved under a human drug application (as defined in section 379g of this title ) or a biosimilar biological product application (as defined in section 379j–51(4) of this title ) and introduced or delivered for introduction into interstate commerce.