Cyltezo an adalimumab biosimilar is now available in USA.- Boehringer.
Boehringer Ingelheim announced Cyltezo (adalimumab-adbm), a 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.
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.