Revision: May 21, 2025, 11:11 a.m.
Senate Health and Human Services
May 21, 2025
2025-2325s
09/05
Amendment to HB 117
Amend RSA 318:47-dd, I as inserted by section 1 of the bill by replacing it with the following:
I. In this section:
(a) "Biological product" means a virus, therapeutic serum, toxin, antitoxin, vaccine, blood, blood component or derivative, allergenic product, protein (except any chemically synthesized polypeptide), or analogous product, or arsphenamine or 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.
(b) "Biosimilar" or "biosimilarity" means:
(1) The biological product is highly similar to the reference product notwithstanding minor differences in clinically inactive components; and
(2) There are no clinically meaningful differences between the biological product and the reference product in terms of the safety, purity, and potency of the product.
[(b)] (c) "Proper name" means the nonproprietary name for a biological product designated by the federal Food and Drug Administration license for use upon each package of the product.
[(c)] (d) "Interchangeable biological product" means a biological product that meets the definition under 42 U.S.C. section 262(i)(3) [the federal Food and Drug Administration:
(1) Has licensed and determined meets the standards for interchangeability pursuant to 42 U.S.C. section 262(k)(4); or
(2) Has determined is therapeutically equivalent as set forth in the latest edition of or supplement to the federal Food and Drug Administration's Approved Drug Products with Therapeutic Equivalence Evaluations].