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The U.S. Food and Drug Administration (FDA) has granted approval to biosimilar adalimumab-adaz high concentration formula (HCF).1
Adalimumab-adaz has been approved for seven indications, aligned with its reference drug adalimumab, including psoriatic arthritis and plaque psoriasis.1
Adalimumab, the active component in adalimumab-adaz, is an inhibitor of tumor necrosis factor (TNF), which is commonly overproduced in autoimmune disorders such as psoriatic arthritis and plaque psoriasis. The overproduction of TNF can result in symptoms such as joint, skin, and mucosal inflammation.1
The U.S. FDA have approved adalimumab-adaz following the results of the phase I pharmacokinetics bridging study which compared adalimumab (50 mg/mL) with adalimumab-adaz (100 mg/mL). The trial met all primary endpoints and adalimumab-adaz was found to have comparable safety, pharmacokinetics, and immunogenicity.1
Novartis. Sandoz receives US FDA approval for biosimilar Hyrimoz® (adalimumab-adaz) high-concentration formulation. https://www.novartis.com/news/media-releases/sandoz-receives-us-fda-approval-biosimilar-hyrimoz-adalimumab-adaz-high-concentration-formulation. Published Mar 21, 2023. Accessed Mar 22, 2023.
The Psoriasis and Psoriatic Arthritis Hub is happy to present a visual abstract summarizing key findings from the phase III PSOARING 3 trial evaluating the long-term...
At the EADV Congress 2022, Papp reported safety and efficacy results at Week 32 from the proof-of-concept phase III, randomized COMFORT trial of piclidenoson in patients with...
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