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FDA OKs High-Concentration of Adalimumab Biosimilar Cyltezo

 FDA OKs High-Concentration of Adalimumab Biosimilar Cyltezo

The US Meals and Drug Administration (FDA) has current the excessive-focus, citrate-free formula of adalimumab-adbm (Cyltezo), a biosimilar of Humira, Boehringer Ingelheim announced.

This excessive-focus formula (100 mg/mL) offers a 50% reduction in injection quantity and is on hand as a prefilled syringe or prefilled autoinjector.

“With this FDA approval, we’re no doubt ready to give each and every excessive- and low-focus, citrate-free formulations of Cyltezo, additional increasing remedy get entry to for patients dwelling with determined persistent inflammatory diseases,” mentioned Stephen Pagnotta, government director and biosimilar business lead at Boehringer Ingelheim, in a bid. “Many patients are handled with excessive-focus adalimumab formulations, and we’re wrathful so as to add this fresh chance to our current citrate-free Cyltezo and adalimumab-adbm choices.”

Adalimumab-adbm is weak in adults to treat moderate to extreme rheumatoid arthritis; moderate to extreme persistent plaque psoriasis; moderate to extreme hidradenitis suppurativa; moderate to extreme ulcerative colitis; psoriatic arthritis; ankylosing spondylitis; and noninfectious intermediate, posterior, and panuveitis. It also has been current to treat moderate to extreme polyarticular juvenile idiopathic arthritis in children frail 2 years or older and moderate to extreme Crohn’s disease in of us frail 6 years or older.

The low focus of adalimumab-adbm launched on July 1, 2023 and became once the first adalimumab biosimilar granted an interchangeability designation, which advance that a pharmacist can exchange the biosimilar for the reference product with out interesting the prescribing clinician. 

The excessive focus model of adalimumab-adbm doesn’t maintain an interchangeable designation from the FDA, a Boehringer Ingelheim spokesperson informed Medscape Scientific News; nonetheless, the company “has acknowledged that Boehringer Ingelheim has fulfilled the requirements to receive the interchangeability designation,” he mentioned. It is miles now now not certain if or when the FDA will grant this designation. 

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