Gov. Christie Signs New Jersey Biosimilar Substitution Law

Legislation Tracker

On Tuesday, Chris Christie, Governor of New Jersey, signed an automatic substitution bill into law that would allow pharmacists to substitute a biological product that has been determined by FDA to be “interchangeable with” or “therapeutically equivalent to” a prescribed biological product unless the prescriber indicated that there should be no substitution.  This is analogous to New Jersey’s current law on automatic substitution for generic drugs (New Jersey Administrative Code § 8:83E-1.19), although it is written permissively, whereas the law for generics is mandatory: the pharmacist “shall” substitute a generic product unless the prescriber indicates no substitution.

New Jersey’s new law on biological substitution does not require a pharmacist to dispense an equivalent product and does not dictate insurance reimbursement rates.  Therefore, this law may not have as strong an effect on the market for branded biologicals drugs as its sister law has on the branded small molecule drug market.

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