Improves access to lower cost generic and biosimilar drugs and revises certain requirements regarding dispensing of biosimilar drugs by pharmacies.*
What changed between versions
Pharmacist substitution of biosimilars changed from permissive ('may substitute') to mandatory ('shall substitute'), meaning pharmacists are now required to swap in a biosimilar when one is available and the prescriber has not blocked substitution.
New section requires insurance carriers and pharmacy benefit managers to immediately review FDA-approved biosimilar or interchangeable drugs with a lower wholesale acquisition cost than the reference product for formulary inclusion. Once included, they must offer the same or more favorable cost sharing and may not impose prior authorization, step therapy, or other restrictions that make it harder to access than the reference product.
New section requires the New Jersey State Board of Pharmacy to maintain a link on its website to the current FDA list of all biosimilars determined to be interchangeable.
The old requirement that pharmacists notify prescribers within five business days when dispensing a biological product was removed and replaced with a simpler provision allowing electronic record entry in an interoperable medical records or pharmacy system, which is presumed to provide notice.
New definitions added to the existing biosimilar law for 'biological product,' 'biosimilar,' 'interchangeable,' 'reference product,' and 'therapeutically equivalent,' all tied to federal FDA standards (Public Health Service Act section 351).
Added liability protection: a pharmacist who substitutes a biosimilar in compliance with the law incurs no greater liability than if they had dispensed the prescribed reference product.
The act's title was broadened from 'supplementing Titles 30 and 52 of the Revised Statutes' to 'amending and supplementing various parts of the statutory law,' reflecting that it now amends existing Title 24 pharmacy statutes in addition to its original provisions.
