NJ Assembly committee approves biosimilar substitution bill
The New Jersey bill is similar to a number of state substitution bills and laws -- from Colorado, Michigan, to North Carolina -- with its notification requirements and intention to ensure the safe dispensing of biosimilars, though it’s different from other state bills as it does not mention the term biosimilar. Virginia, Indiana, North Dakota, Delaware, Florida, Utah, Oregon and Massachusetts have all passed biosimilar substitution bills.
Critics of this patchwork of state legislation have previously said some of the laws could hamper biosimilar adoption and run counter to federal law.
New Jersey Assembly Deputy Republican Leader Nancy Muñoz said in a statement that the bill is needed to ensure that once the FDA has approved a biosimilar as “interchangeable” with a biologic, a law is in place to address the issue of substitution.
FDA spokesman Kristofer Baumgartner previously told us that the Biologics Price Competition and Innovation Act “expressly states that an interchangeable biological product may be substituted for the reference product without the intervention of the health care provider who prescribed the reference product.
“The high standards for approval of biosimilar and interchangeable products mean that patients and health care professionals can be assured that, when these products go to market, they will meet the standards of safety, efficacy and high quality that everyone expects and counts on,” Baumgartner said.
The FDA has yet to release draft guidance for the industry on how it will determine interchangeability.
NJ Details
The New Jersey bill specifies that pharmacists “will be required to communicate to the prescriber, within five business days, the specific product provided to the patient, including the name of the product and the manufacturer,” and preferably in an electronic manner.
A number of other states, such as North Carolina and Colorado, insist that in order for a biosimilar to be dispensed, it has to be declared interchangeable by the US FDA. The New Jersey bill, however, states that no communication between a prescriber and pharmacist would be required when there is no other biologic deemed by the FDA “to be interchangeable or therapeutically equivalent to the product prescribed.”
The FDA has only approved one biosimilar so far – Sandoz’s Zarxio -- and it was not approved as interchangeable.
The New Jersey bill also requires the pharmacist to record, on the prescription label and record of dispensing, the product name and manufacturer of the biological product dispensed, followed by the words: “Substituted for” and the name of the biological product for which the prescription was written.
In addition, the bill says that a pharmacist who meets these requirements in dispensing and substituting biosimilars for its reference product “would incur no greater liability for dispensing the substituted product than would be incurred for dispensing the prescribed product.”
