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FDA approves Boehringer Ingelheim’s Cyltezo for inflammatory ailments
2024-05-02
上市批准临床3期临床1期基因疗法
The FDA approval allows Boehringer Ingelheim’s Cyltezo to be used as an interchangeable biosimilar to Humira. Credit: Tada Images/ Shutterstock.com.
The FDAFood and Drug AdmBoehringer Ingelheims aCyltezo Boehringer Ingelheim’s high-concentration, citrHumiraee formulation of Cyltezo (adalimumab-adbm), an interchangeable biosimilar to Humira (adalimumab).
This apFood and Drug Administration (FDA)n the treatmenBoehringer Ingelheimc inflammatory diseases.Cyltezoadalimumab-adbmHumira (adalimumab)
The newly approved foCyltezoon has a 100mg/mL concentration and is ofchronic inflammatory diseases 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 thCyltezot since July 2023.Adalimumab-adbm
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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.
Janssen-Cilagnitially approveEMAy the US regulTREMFYA 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 fFDAsed on the impact of multiple switches between Humira and Cyltezo versus continuous treatment with Humira alone.adalimumab-adbm
Cyltezoger Ingelheim Biosimilar commercial lead and executive director Stephen PagnottaHumirad: “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.”
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