FDA Approves Citrate-Free Cyltezo® (Adalimumab-adbm) Injection

Boehringer Ingelheim has announced that the U.S. Food and Drug Administration (FDA) has approved a new high-concentration, citrate-free formulation of Cyltezo® (adalimumab-adbm). This biosimilar to Humira® is now available to treat various chronic inflammatory diseases. The approval expands the treatment options for patients, offering both high- and low-concentration formulations of Cyltezo. The high-concentration formulation, which is 100 mg/mL, is available in pre-filled syringes or autoinjectors and is priced at a 5% discount to Humira under the Cyltezo brand and an 81% discount as the unbranded product Adalimumab-adbm. The low-concentration formulation has been available since July 2023.

Stephen Pagnotta, Executive Director and Biosimilar Commercial Lead at Boehringer Ingelheim, emphasized the significance of this approval in broadening treatment access for patients with chronic inflammatory diseases. He noted that many patients are already using high-concentration adalimumab, and this new option will enhance their treatment possibilities.

Michael Osso, President & CEO of the Crohn's & Colitis Foundation, welcomed the new high-concentration, citrate-free formulation, highlighting its importance for patients with conditions like Crohn's disease and ulcerative colitis. He pointed out that having multiple biosimilar formulations aids in broader patient access to biologic medicines.

Steven Taylor, President & CEO of the Arthritis Foundation, also praised the FDA approval, stating that it marks progress for people with chronic diseases such as rheumatoid and psoriatic arthritis. Taylor expressed support for the broader adoption of biosimilars, which he believes benefit both patients and the healthcare system.

Leah M. Howard, J.D., President and CEO of the National Psoriasis Foundation, echoed similar sentiments, underlining the critical role of biologics and biosimilars in treating conditions like psoriatic arthritis and psoriasis. She welcomed the new formulation, noting that it offers more options for the community.

The FDA's approval was partly based on data from the VOLTAIRE-HCLF Phase I clinical trial, which compared the bioavailability of high-concentration and low-concentration formulations of adalimumab-adbm.

Cyltezo received FDA approval as an interchangeable biosimilar to Humira on October 15, 2021. Its efficacy and safety are supported by extensive data, including from the Phase III VOLTAIRE-X clinical trial, which studied the effects of switching between Humira and Cyltezo compared to continuous treatment with Humira.

Boehringer Ingelheim, one of the largest producers of biologic medicines globally, aims to increase the availability of safe, effective therapeutic options through its biologics and biosimilars. The company's biopharmaceutical contract manufacturing business has helped bring numerous biologics to market in various therapeutic areas, including oncology, immunology, and cardiovascular indications.

Cyltezo is used to treat several conditions, including moderate to severe rheumatoid arthritis in adults, polyarticular juvenile idiopathic arthritis in children aged two years and older, psoriatic arthritis, ankylosing spondylitis, hidradenitis suppurativa, Crohn's disease in adults and children aged six years and older, ulcerative colitis in adults, chronic plaque psoriasis in adults, and non-infectious uveitis in adults.

Patients considering Cyltezo should discuss potential benefits and risks with their doctors. It is important to be aware of serious infections, the risk of certain cancers, and other side effects associated with TNF blockers like Cyltezo. Patients should inform their doctors of their full medical history and any other medications they are taking before starting Cyltezo.

The most common side effects include injection site reactions, upper respiratory infections, headaches, and rash. Patients should immediately report any signs of infection or other serious side effects to their healthcare provider.