This bill amends the definition of "interchangeable biological product" and establishes guidelines for pharmacists regarding the substitution of biological products. It introduces new definitions for "biosimilar" and "biosimilarity," which clarify that a biological product must be highly similar to a reference product with no clinically meaningful differences in safety, purity, and potency. The bill also modifies the definition of "interchangeable biological product" to align with federal standards, specifically referencing 42 U.S.C. section 262(i)(3).

Additionally, the bill outlines the conditions under which pharmacists can substitute a prescribed biological product with an interchangeable one, including the requirement to inform patients of the substitution. It prohibits substitution if the prescriber indicates that it is not authorized or if the patient expresses a preference against receiving an interchangeable product. Furthermore, the bill mandates that pharmacists document the specific product dispensed and communicate this information to the prescriber within three business days. The effective date of the act is set for 60 days after its passage.

Statutes affected:
Introduced: 318:47-dd
As Amended by the Senate: 318:47-dd
Version adopted by both bodies: 318:47-dd
CHAPTERED FINAL VERSION: 318:47-dd