FDA approves supplemental application for Cyltezo as interchangeable biosimilar for Humira.- Boehringer

The approval for Interchangeability was supported by positive data from Boehringer's Phase III randomized VOLTAIRE-X clinical trial and marks the first FDA approval for such a study. The VOLTAIRE-X trial studied the effects of multiple switches between Humira and Cyltezo. This additional study demonstrated that Cyltezo is equivalent to Humira with no meaningful clinical differences in pharmacokinetics, efficacy, immunogenicity, and safety between the switching and continuous treatment groups. The results were presented at the American Academy of Dermatology 2021 conference.

To be designated as an interchangeable product by the FDA, a biosimilar must also be “expected to produce the same clinical result as the reference product in any given patient” and “not present greater risks in terms of safety or diminished efficacy from alternating or switching” between the interchangeable candidate and reference product. A biosimilar with an interchangeable designation can be substituted by a pharmacist for the reference product without involving the prescriber, consistent with state law.