FDA has not yet approved a biosimilar, let alone decided whether a biosimilar is interchangeable with a biologic reference product. But brand-name biologic companies and those pursuing generic versions of the reference products have been battling over whether pharmacists must notify doctors when making a substitution, an additional step that could restrict patient access to biosimilars. The parties recently reached an agreement in lobbying states for regulations pertaining to substitution. The compromise language, which closely resembles the recently passed Massachusetts law, allows the pharmacist to notify the prescriber of the substitution "within a reasonable time following the dispensing of a biological product," rather than before the product is dispensed. The compromise also allows for the use of technology, conveying the information to prescribers using electronic medical records systems.
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