Boehringer Ingelheim has secured the US Food and Drug Administration (FDA) approval for the high-concentration, citrate-free formulation of Cyltezo (adalimumab-adbm), an interchangeable biosimilar to Humira (adalimumab) for certain inflammatory diseases.
Cyltezo is a medicine designed to block tumour necrosis factor (TNF).
The approval is partially based on data gathered from the VOLTAIRE-HCLF clinical trial.
It is a Phase 1 study that assessed the bioavailability of high-concentration and low-concentration formulations of Cyltezo.
Boehringer Ingelheim executive director and biosimilar commercial lead Stephen Pagnotta said: “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 high-concentration formulation, now offered as a pre-filled syringe or autoinjector, is priced at a 5% discount to Humira when sold under the Cyltezo brand.
It is available at an 81% reduction when sold as Adalimumab-adbm, an unbranded medicine.
Cyltezo`s citrate-free, low-concentration formulation has been commercially available since July 2023.
It received FDA approval as an interchangeable biosimilar to Humira in 2021.
Cyltezo`s efficacy and safety are backed by extensive data, notably from the Phase 3 randomised VOLTAIRE-X comparative clinical trial.
The study investigated the impact of multiple switches between Humira and Cyltezo compared to continuous treatment with the former.
A biosimilar is a biological medicine designed to closely resemble an approved reference biologic with no clinically significant safety, potency, and purity variances.
If designated as interchangeable by the FDA, the biosimilar can be substituted for the reference product by a pharmacist.
Earlier this year, Alvotech and Teva Pharmaceuticals secured FDA approval for Simlandi (adalimumab-ryvk) injection, also an interchangeable biosimilar to Humira.
