FDA OKs High-Concentration of Adalimumab Biosimilar Cyltezo

The US Food and Drug Administration (FDA) has approved the high-concentration, citrate-free formulation of adalimumab-adbm (Cyltezo), a biosimilar of Humira, Boehringer Ingelheim announced.

This high-concentration formulation (100 mg/mL) offers a 50% reduction in injection volume and is available as a prefilled syringe or prefilled autoinjector.

"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," said Stephen Pagnotta, executive director and biosimilar commercial lead at Boehringer Ingelheim, in a press 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."

Adalimumab-adbm is used in adults to treat moderate to severe rheumatoid arthritis; moderate to severe chronic plaque psoriasis; moderate to severe hidradenitis suppurativa; moderate to severe ulcerative colitis; psoriatic arthritis; ankylosing spondylitis; and noninfectious intermediate, posterior, and panuveitis. It also has been approved to treat moderate to severe polyarticular juvenile idiopathic arthritis in children aged 2 years or older and moderate to severe Crohn's disease in people aged 6 years or older.

The low concentration of adalimumab-adbm launched on July 1, 2023 and was the first adalimumab biosimilar granted an interchangeability designation, meaning that a pharmacist can substitute the biosimilar for the reference product without involving the prescribing clinician. 

The high concentration version of adalimumab-adbm does not have an interchangeable designation from the FDA, a Boehringer Ingelheim spokesperson told Medscape Medical News; however, the agency "has acknowledged that Boehringer Ingelheim has fulfilled the requirements to receive the interchangeability designation," he said. It is not clear if or when the FDA will grant this designation.