Georgia biosimilar substitution bill calls for labeling changes, heads to Governor for signature
If approved, this would among the first bills introduced by a state that goes so far as to request label changes for biosimilars in addition to prescriber notification requirements that many other substitution laws also require. Delaware is the only state to pass legislation that requires pharmacists to note on the label that the product dispensed is an interchangeable biosimilar, while previous legislation in Texas and Arizona proposed labeling changes but ultimately failed, according to the Journal of Law and Biosciences.
Industry group BIO is calling for Georgia Governor Nathan Deal (R) to sign the bill into a law though the group did not make any reference the proposed label changes.
The FDA told BioPharma-Reporter.com that it will not take an official stand on any of the state legislation, though all of the new state requirements around the dispensing of biosimilars seems to run counter to a 2010 federal law, the Biologics Price Competition and Innovation Act.
FDA spokesman Kristofer Baumgartner told us that the 2010 law “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,” he added. “Efforts to undermine trust in these products are worrisome and represent a disservice to patients who could benefit from these lower cost treatments.”
Details of the Georgia Bill
Although BIO and supporters are framing the bill as a way to help biosimilar substitution, the bill itself seems concerned more with the labeling of the biosimilar drug.
Georgia bill SB 51 says: “If a pharmacist substitutes an interchangeable biological product for a prescribed biological product when dispensing a prescribed medication, the name of the interchangeable biological product, with an explanation of 'interchangeable biological product for (insert name of prescribed biological product)' or similar language to indicate substitution has occurred, must appear on the prescription label and be affixed to the container or an auxiliary label, unless the prescribing practitioner indicated that the name of the biological product may not appear upon the prescription label.”
However, the label changes will not apply for biologics “dispensed for in-patient hospital services, to hospital administered biological products for outpatients, or to biological products in specialty packaging for dosing purposes as defined by the board,” the bill says.
As far as the notification requirements, pharmacists will have 48 hours, excluding weekends and holidays, to communicate to the prescriber the specific product provided to the patient, including the name of the biosimilar and the manufacturer.
The state board of pharmacy is also required to maintain a link on its website to the current list of all biological products determined by the FDA to be interchangeable with a specific biologic.
