What Are Interchangeable Biologic Products?

According to the BPCIA, for a biosimilar product to be designated as interchangeable, the manufacturer must provide additional evidence that the biosimilar is expected to produce the same clinical result as the reference product in any given patient. In addition, the manufacturer must show that patients may use both products safely and without any loss in efficacy. Specifically, if the biosimilar is administered more than once to a patient, the risk (in terms of safety or reduced effectiveness) associated with alternating or switching between the biosimilar and the reference product cannot be greater than the risk of using the reference product continuously.

None of the biosimilar products approved so far in the United States have been designated as interchangeable.