New Jersey Statutes Title 24. Food and Drugs 24 § 6K-1

As used in this act:

“Biological product” means a “biological product” as defined in subsection (i) of section 351 of the Public Health Service Act (42 U.S.C. s.262(i)), and refers to a virus, therapeutic serum, toxin, antitoxin, vaccine, blood, blood component or derivative, allergenic product, protein other than a chemically synthesized polypeptide, or analogous product, or arsphenamine or any derivative of arsphenamine or any other trivalent organic arsenic compound, applicable to the prevention, treatment, or cure of a disease or condition of human beings.

“Interchangeable” means “interchangeable” as defined in subsection (i) of section 351 of the Public Health Service Act (42 U.S.C. s.262(i)) and indicated as interchangeable by the federal Food and Drug Administration in the “Lists of Licensed Biological Products with Reference Product Exclusivity and Biosimilarity or Interchangeability Evaluations,” sometimes referred to as the “Purple Book.”

“Therapeutically equivalent” means a therapeutic equivalence rating of “A” has been listed by the federal Food and Drug Administration in the “Approved Drug Products with Therapeutic Equivalence Evaluations,” sometimes referred to as the “Orange Book.”