The US Food and Drug Administration (FDA) has approved Boehringer Ingelheim‘s high-concentration, citrate-free formulation of Cyltezo (adalimumab-adbm), an interchangeable biosimilar to Humira (adalimumab).

This approval allows Cyltezo to be used in the treatment of multiple chronic inflammatory diseases.

The newly approved formulation has a 100mg/mL concentration and is offered as a pre-filled syringe or pre-filled autoinjector.

It is priced competitively at a 5% discount to Humira when branded as Cyltezo and at an 81% discount when offered as the unbranded product Adalimumab-adbm.

The lower concentration version of Cyltezo, at 50mg/mL, has been on the market since July 2023.

The latest FDA approval draws upon data from the VOLTAIRE-HCLF clinical trial, a Phase I study that compared the bioavailability of the high-concentration and low-concentration formulations of adalimumab-adbm.

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Cyltezo was initially approved by the US regulator as an interchangeable biosimilar to Humira in October 2021.

The asset’s efficacy and safety were substantiated by extensive research, including results from the Phase III VOLTAIRE-X clinical trial.

The study focused on the impact of multiple switches between Humira and Cyltezo versus continuous treatment with Humira alone.

Boehringer Ingelheim Biosimilar commercial lead and executive director Stephen Pagnotta stated: “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.

“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 latest development comes after Boehringer Ingelheim and Ochre Bio entered a strategic collaboration to discover and develop new regenerative treatments for chronic liver diseases.