Pharmacy Practice FAQsBIOSIMILARS
Q: May a pharmacist substitute an interchangeable biosimilar when presented with a prescription authorizing substitution for the “brand” product? A: Yes. GS § 90-85.28(a) allows a pharmacist to select an “interchangeable biological product” when the prescriber authorizes substitution for a brand name product. A pharmacist who dispenses an interchangeable biosimilar to a patient must, within five business days, “communicate to the prescriber the product name and manufacturer of the specific biological product dispensed to the patient.” The statute lists five means of making this communication electronically. An entry into any of the following “that is electronically accessible to the prescriber” by “the pharmacist or a designee is presumed to provide the required communication and notice to the prescriber”: “(1) An interoperable electronic medical records system. (2) Electronic prescribing technology. (3) A pharmacy benefit management system. (4) The North Carolina Health Information Exchange Network. (5) A pharmacy record.” Absent one of these methods, the statute says that “the pharmacist or a designee shall provide the required communication to the prescriber by facsimile, telephone, electronic transmission, or other prevailing means.” The statute specifies that there is no required communication to the prescriber if there is no FDA-approved interchangeable biosimilar for the product prescribed or if a refill prescription is not changed from the product dispensed on the prior filling of the prescription.” GS § 90-85.28(b2)
Q: How do I determine whether a drug product has, or is, an “interchangeable biosimilar”? A: The FDA maintains the Purple Book, which lists biological products, including any biosimilar or interchangeable biosimilar licensed by FDA under the Public Health Service Act (the PHS Act). The lists include the date a biological product was licensed under 351(a) of the PHS Act and whether FDA evaluated the biological product for reference product exclusivity under section 351(k)(7) of the PHS Act. The Purple Book will also enable a user to see whether a biological product licensed under section 351(k) of the PHS Act has been determined by FDA to be biosimilar to or interchangeable with a reference biological product (an already-licensed FDA biological product). Biosimilar and interchangeable biological products licensed under section 351(k) of the PHS Act will be listed under the reference product to which biosimilarity or interchangeability was demonstrated.
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