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# High-Concentration Humira Biosimilar OK’d
- URL: https://www.fdaweb.com/high-concentration-humira-biosimilar-okd/
- Published: 2024-05-01T12:00:00.000Z
- Updated: 2026-09-14T14:29:44.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5156898

FDA has approved Boehringer Ingelheim’s high-concentration, citrate-free formulation of Cyltezo (adalimumab-adbm), an interchangeable biosimilar to Abbvie’s Humira (adalimumab) for treating multiple chronic inflammatory diseases. Boehringer’s low-concentration (50 mg/mL), citrate-free formulation of Cyltezo has been commercially available since 7/2023\. “The availability of a high-concentration and citrate-free Cyltezo is welcome news for people living with certain chronic inflammatory conditions, such as Crohn’s disease and ulcerative colitis, which affect nearly 1 in 100 Americans,” the company says.

Approval was based in part on data from the company’s [VOLTAIRE-HCLF](https://www.boehringer-ingelheim.com/us/external-link?external=https%3A%2F%2Fclinicaltrials.gov%2Fstudy%2FNCT05203289&ref=fdaweb.com), a Phase 1 clinical trial comparing the bioavailability of high-concentration and low-concentration formulations of adalimumab-adbm. “The efficacy and safety of Cyltezo are supported by a large body of data, including the Phase3 randomized VOLTAIRE-X comparative clinical trial, which studied the effects of multiple switches between Humira and Cyltezo compared to continuous treatment with Humira,” Boehringer says.