Voltaire-X Phase 3 Data for Chronic Plaque Psoriasis Support Interchangeability Application

Boehringer Ingelheim recently announced results from a phase 3, randomized study that concluded that switching several times from Humira® (adalimumab) to Cyltezo® (adalimumab-adbm) produced similar clinical outcomes in terms of pharmacokinetics, efficacy, immunogenicity, and safety in people with moderate to severe chronic plaque psoriasis. The 32-week data will be presented at the American Academy of Dermatology 2021 virtual meeting experience.

“We are proud to present the results from Voltaire-X, a landmark study that supports Boehringer Ingelheim’s application for interchangeability between Cyltezo and Humira,” said Thomas Seck, senior vice president, medicine and regulatory affairs at Boehringer Ingelheim. “This first-of-its-kind switching study further reinforces our goal to broaden access to biosimilar treatment options while contributing to the quality and sustainability of healthcare systems.”

A biosimilar is a biological medicine that is developed to be highly similar to an approved reference biologic, with no clinically meaningful differences in terms of quality, safety, potency, and purity. To be designated as an interchangeable product by the U.S. Food and Drug Administration (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.

VOLTAIRE-X (NCT 03210259), a phase 3, interchangeability study with the U.S.-marketed, original formulation of Humira, 40mg/0.8mL, randomized 238 patients to assess the following:

1. Pharmacokinetic similarity between patients with moderate to severe chronic plaque psoriasis receiving Humira continuously versus those who switched several times between Cyltezo and Humira.
2. Comparison of the efficacy, immunogenicity, and safety profiles between patients receiving Humira continuously versus those who switched several times between Cyltezo and Humira.

Patients with moderate to severe chronic plaque psoriasis received Humira and were then randomized to ‘switching’ or ‘continuous’ treatment. Baseline characteristics were generally balanced between groups. The data supports Cyltezo’s application for designation as an interchangeable biosimilar to Humira, based on outcomes between the switching and continuous treatment groups, in pharmacokinetics, efficacy, immunogenicity, and safety.

These results continue to build on the existing analytical, pharmacological, non-clinical similarity data as well as the clinical data in Crohn’s Disease and in the rheumatoid arthritis population, which were used to support the approval of Cyltezo by the FDA in 2017.

Boehringer Ingelheim has submitted a supplemental biologics license application (sBLA) for Cyltezo for designation as an interchangeable biosimilar to Humira. The action date is scheduled for the 4th quarter of 2021.

Cyltezo is not commercially available in the U.S. at this time, but its commercial license will begin on July 1, 2023.

Reference:

VOLTAIRE-X phase III data in patients with moderate-to-severe chronic plaque psoriasis support interchangeability application. Boehringer Ingelheim. April 23, 2021. Accessed April 24, 2021. https://www.boehringer-ingelheim.us/press-release/voltaire-x-phase-iii-data-patients-moderate-severe-chronic-plaque-psoriasis-support