FDA Approves High-Concentration Cyltezo for Treatment of Chronic Inflammatory Diseases

The US Food and Drug Administration (FDA) has approved high-concentration, citrate-free adalimumab-adbm, branded as Cyltezo, for the treatment of chronic inflammatory diseases.

Cyltezo is an interchangeable biosimilar to adalimumab (Humira) and is now available as a prefilled syringe or prefilled autoinjector at a high concentration (100 mg/mL) at a discounted price compared with Humira. A low-concentration version (50 mg/mL) has been available commercially since 2023.

“This FDA approval is another step forward for people with chronic and often debilitating diseases such as rheumatoid and psoriatic arthritis,” said Steven Taylor, president and CEO of the Arthritis Foundation, in a press release. “We stand united with our patients and health care providers in the effort to accelerate the adoption of biosimilars, which benefit patients as well as the larger health care ecosystem.”

Approval is based in part on data from the VOLTAIRE-HCLF clinical trial. The phase 1 trial compared high- versus low-concentration Cyltezo. This tumor necrosis factor blocker is used to reduce the signs and symptoms of:

• Moderate-to-severe rheumatoid arthritis in adults
• Moderate-to-severe polyarticular juvenile idiopathic arthritis in children aged 2 years and older
• Psoriatic arthritis in adults
• Ankylosing spondylitis in adults
• Moderate-to-severe hidradenitis suppurativa in adults

It is also used to treat moderate-to-severe Crohn disease in adults and children aged 6 years and older, ulcerative colitis in adults, and chronic plaque psoriasis in adults. Additionally, it is used to treat noninfectious intermediate, posterior, or panuveitis in adults. Cyltezo comes with a boxed warning for serious infections (tuberculosis, bacterial sepsis, invasive fungal infections, and other infections due to opportunistic pathogens) and malignancy (lymphomas, including hepatosplenic T-cell lymphoma, and other malignancies).