According to the FDA, an interchangeable product is a biological product that is
approved based on data demonstrating that it is highly similar to an FDA-approved reference product
and that there are no clinically meaningful differences between the products. The interchangeable
product can be expected to produce the same clinical result as the reference product in any given
patient. Further, if the interchangeable product is administered more than once to a patient, the
risk in terms of safety or diminished efficacy from alternating or switching between use of the
reference product and interchangeable product is not greater than that from the reference product
without such alternation or switch.
Interchangeability of SEMGLEE has been demonstrated for the condition(s) of use,
strength(s), dosage form(s), and route(s) of administration described in its Full Prescribing
Information.
An interchangeable biologic product is a biosimilar that meets additional
requirements and may be substituted for the reference product at the pharmacy, depending on state
pharmacy laws.