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Automated measurement devices are not necessarily interchangeable substitutes for GAT.
Once a biologic is deemed interchangeable, it can be substituted by pharmacists without permission from a doctor.
There are two programs P and Q which are not bisimilar, but nontheless are interchangeable: one may be substituted for the other anywhere in a CCS program and no difference can be seen.
A product found by the FDA to be interchangeable could be freely substituted for the original product.
This would also be the case if interchangeable biologics are automatically substituted.
"Interchangeable" products may be substituted for the reference product without the intervention of the prescribing healthcare provider.
The BPCI Act states that an interchangeable biologic "may be substituted for the reference product without the intervention of the healthcare provider who prescribed the reference product" 10.
For example, a recently passed Delaware Senate bill includes a requirement for the pharmacist to record the name and manufacturer of a biologic product within 10 days of dispensing the product when an FDA-approved interchangeable biologic product is substituted for a prescribed reference biologic product.
The term "interchangeable" or "interchangeability", in reference to a biological product that is shown to meet the standards described in subsection (k)(4), means that the biological product may be substituted for the reference product without the intervention of the health care provider who prescribed the reference product.
The BPCI Act states that the interchangeable "biological product may be substituted for the reference product without the intervention of the health care provider who prescribed the reference product" [ 7].
In the context of biologic medicines, many are anticipated to be approved without a determination of interchangeability, whereas some biosimilars may ultimately be licensed as interchangeable biologics that may be automatically substituted for the prescribed reference biologic [ 51].
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