Biosimilar Update: Humira Biosimilar Cyltezo Now Available in U.S.


Boehringer Ingelheim’s Cyltezo is the only adalimumab biosimilar with Phase III comparative clinical studies in rheumatoid arthritis, plaque psoriasis and Crohn's disease.

Boehringer Ingelheim’s Cyltezo (adalimumab-adbm), a U.S. Food and Drug Administration (FDA)-approved Interchangeable biosimilar to Humira (adalimumab), is now commercially available in the U.S. 

Cyltezo was initially approved as a biosimilar in 2017 for use in multiple chronic inflammatory diseases. Cyltezo was approved as an Interchangeable biosimilar in 2021, and is available as a prefilled syringe, or as a Cyltezo Pen autoinjector.

"Cyltezo is the first and only FDA-approved Interchangeable biosimilar to Humira that is available to the millions of people in the U.S. living with certain chronic inflammatory diseases," says Stephen Pagnotta, Executive Director and Biosimilar Commercial Lead at Boehringer Ingelheim, in a news release. "Cyltezo reinforces our ultimate goal of providing a more affordable and accessible treatment option for this community, and we look forward to seeing the impact it will have across the U.S."

The efficacy and safety of Cyltezo are supported by a large body of data, including the Phase III randomized VOLTAIRE-X comparative clinical trial, which studied the effects of multiple switches between Humira and Cyltezo compared to continuous treatment with Humira. The results of VOLTAIRE-X were presented at the 2021 American Academy of Dermatology Annual Meeting. Pharmacokinetic equivalence was demonstrated, with highly similar efficacy and immunogenicity, and comparable safety observed in patients who received either Humira continuously or who switched between Humira and Cyltezo.

"For many people living with plaque psoriasis or psoriatic arthritis, finding effective relief from symptoms can be a daily struggle. We're always happy to have new treatment options that may help reduce the severity of symptoms and improve the quality of life for patients living with this disease," says Leah M. Howard, J.D., President and CEO, the National Psoriasis Foundation.  

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