The Academy of Managed Care Pharmacy (AMCP) is writing to express concerns with specific provisions of Substitute Bill No.7118 regarding the regulation of biological products and the substitution of interchangeable biological products when dispensed by pharmacists. We strongly support the language in the Substitute Bill that allows a pharmacist to substitute an FDA approved “interchangeable biological product”. That language is consistent with the Biologics Competition and Innovation Act (BPCIA) definition of “interchangeable biologic product” which allows a pharmacist to substitute an interchangeable biologic product without the intervention of the health care provider who prescribed the “reference product”. However, we oppose the language that defines an interchangeable biological product as therapeutically equivalent and imposes administrative requirements to dispense an interchangeable biological product that are different from existing requirements for all other classes of medications. We also are concerned about enacting requirements prior to the FDA finalizing guidance on interchangeable biological products.
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