Tennessee Governor Bill Haslam this week signed TN Senate Bill 984 into law, creating a clear pathway for pharmacists in Tennessee to substitute an FDA-approved “interchangeable biological product” for a prescribed biological product. As we discussed in an earlier post, Life Science Tennessee lobbied for the bill during the organization’s annual legislative “Day on the Hill” at the Tennessee General Assembly back in March.
Following passage of the Affordable Care Act, manufacturers of biological drug products now have an abbreviated licensure pathway to obtain approval of biological products that are therapeutically equivalent (called “biosimilars”) to approved biological products.While the FDA approved the first biosimilar product (Novartis’ Zarxio) in March of this year, the agency has not yet designated any biological products as “interchangeable” with another biological product (for the FDA to designate a biological product as “interchangeable”, the product must be shown to have no clinically meaningful differences with an approved product (i.e., biosimilar), and it must be expected to produce the same clinical result as the approved product in any given patient). The FDA expects to receive applications for interchangeability designation as early as this year.
With the passage of Senate Bill 984, a dispensing pharmacist in Tennessee will have the discretion to substitute a biological product that has been designated by the FDA as interchangeable for a brand name biological product, unless the prescribing physician has indicated otherwise.The law also implements new rules for communication of prescribing instructions and substitution information among prescribers, pharmacists and patients.