US: FDA approves high-concentration, citrate-free formulation of Cyltezo® (adalimumab-adbm) injection

The high-concentration, citrate-free formulation of Cyltezo (adalimumab-adbm), an interchangeable biosimilar to Humira (adalimumab) developed by German family-owned pharmaceutical giant Boehringer Ingelheim, has been approved by the US Food and Drug Administration (FDA) for the treatment of certain chronic inflammatory conditions.

“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. “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.”

Cyltezo’s low-concentration, citrate-free formulation was first authorized in August 2017.

Extensive data, including results from the VOLTAIRE-HCLF experiment (ClinicalTrials.gov Identifier: NCT05203289), were used to support the FDA clearance. After a single subcutaneous injection, the pharmacokinetics of Cyltezo’s high-concentration and low-concentration formulations were evaluated in this study.

Roughly 80% of prescriptions for adalimumab are for high-concentration medication. This approval, which comes after Hadlima, Hyrimoz, Yuflyma, and Simlandi, is the sixth for a high-concentration adalimumab. Cyltezo, Hadlima, and Hyrimoz are the only products with a high-concentration formulation that are also available in a low-concentration formulation.

“Biologics and biosimilars are a crucial treatment option for many living with psoriatic arthritis or psoriasis,” said Leah M. Howard, J.D., President and CEO of the National Psoriasis Foundation. “We welcome the introduction of this additional formulation to expand the array of options available to our community.”