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

Switching between adalimumab biosimilar Cyltezo and its reference product results in similar pharmacokinetics, efficacy, safety and immunogenicity in people with moderate-to-severe chronic plaque psoriasis, according to new Phase 3 data presented at the American Academy of Dermatology 2021 virtual meeting experience (AAD VMX). 

At week 32, the study met the primary endpoint, supporting Cyltezo’s application as an interchangeable biosimilar to Humira (adalimumab). Cyltezo Manufacturer Boehringer Ingelheim has submitted a supplemental biologics license application for Cyltezo for designation as an interchangeable biosimilar to Humira.  The action date is scheduled for the 4th quarter of 2021.

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:

•          Pharmacokinetic similarity between patients with moderate-to-severe chronic plaque psoriasis receiving Humira continuously versus those who switched several times between Cyltezo and Humira  

•          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. 

“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,” says Thomas Seck, Senior Vice President, Medicine and Regulatory Affairs at Boehringer Ingelheim, in a news release. “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.”

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