FDA OKs High-Concentration of Adalimumab Biosimilar Cyltezo

This high-concentration formulation offers a 50% reduction in injection volume and is available as a prefilled syringe or prefilled autoinjector.

"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, in a press release.

Adalimumab-adbm is used in adults to treat moderate to severe rheumatoid arthritis; moderate to severe chronic plaque psoriasis; moderate to severe; psoriatic arthritis; ankylosing spondylitis; and noninfectious intermediate, posterior, and panuveitis.

The high concentration version of adalimumab-adbm does not have an interchangeable designation from the FDA, a Boehringer Ingelheim spokesperson told; however, the agency"has acknowledged that Boehringer Ingelheim has fulfilled the requirements to receive the interchangeability designation," he said. It is not clear if or when the FDA will grant this designation.

RA - Rheumatoid Arthritis Rheumatoid Arthritis (RA) Biologic Therapy Biologics Uveitis Biosimilars Biosimilar Drugs Follow-On Biologics Grant Psoriatic Arthritis Arthropathic Psoriasis Psoriatic Arthropathy Psa Juvenile Rheumatoid Arthritis Juvenile Ra Juvenile Idiopathic Arthritis Ankylosing Spondylitis Rheumatoid Spondylitis Rheumatoid Arthritis Of The Spine

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