Boehringer Ingelheim has initiated a clinical study, VOLTAIRE-X, to investigate the interchangeability between BI 695501, an adalimumab biosimilar candidate, and Humira 40mg/0.8mL. This is the first U.S. study to examine an interchangeability designation for an adalimumab biosimilar candidate.
An interchangeable biologic refers to a biosimilar that produces the same clinical outcome as the reference product in any patient. The Food and Drug Administration (FDA)’s interchangeability designation indicates that the biosimilar may be substituted by a pharmacist for the reference product without intervention from the prescriber, subject to individual state law.
VOLTAIRE-X (n=240) is being conducted in patients with moderate-to-severe chronic plaque psoriasis. Researchers will compare the pharmacokinetics and clinical outcomes between patients continuously receiving Humira vs. repeatedly switching between Humira and BI 695501. In addition, the study will evaluate safety, efficacy, and immunogenicity.
BI 695501 has been accepted by the FDA for regulatory review. Phase 3 data supporting its clinical equivalence to Humira in patients with rheumatoid arthritis were presented at the recent European Congress of Rheumatology.
The VOLTAIRE-X study data are expected to be available in the second half of 2019.
For more information visit Boehringer-Ingelheim.us.