The U.S. Food and Drug Administration (FDA) has approved the high-concentration, citrate-free formulation of Cyltezo (adalimumab-adbm), the company’s interchangeable biosimilar to Humira (adalimumab), to treat multiple chronic inflammatory diseases including psoriasis.
“With this FDA approval, we are now able to offer both high- and low-concentration, citrate-free formulations of Cyltezo, further expanding treatment access for patients living with certain chronic inflammatory diseases,” says Stephen Pagnotta, Executive Director and Biosimilar Commercial Lead at Boehringer Ingelheim, in a news release. “Many patients are treated with high-concentration adalimumab formulations, and we are excited to add this new option to our approved citrate-free Cyltezo and Adalimumab-adbm offerings.”
The high-concentration formulation (100 mg/mL), which is now available as a pre-filled syringe or pre-filled autoinjector, is priced at a 5% discount to Humira under the brand name Cyltezo and at an 81% discount to Humira as the unbranded product Adalimumab-adbm. The low-concentration (50 mg/mL), citrate-free formulation of Cyltezo has been commercially available since July 2023.
“Biologics and biosimilars are a crucial treatment option for many living with psoriatic arthritis or psoriasis,” says Leah M. Howard, JD, President and CEO of the National Psoriasis Foundation, in a news release. “We welcome the introduction of this additional formulation to expand the array of options available to our community.”
Citrate-free formulations improve the patient experience with significantly less injection site pain and erythema.
The FDA approval is based, in part, on data from clinical trial VOLTAIRE-HCLF, a Phase I clinical trial comparing the bioavailability of high-concentration and low-concentration formulations of adalimumab-adbm.
The FDA approved Cyltezo as an interchangeable biosimilar to Humira on October 15, 2021. 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.
