Drug intelligence / Profile preview

AVT02

Development stage
Approved
Lead developer
Alvotech
Modality
Monoclonal Antibodies → Antibody-Based Therapeutics
Administration
Subcutaneous
01

Overview

**AVT02** is a high-concentration (100 mg/mL), citrate-free biosimilar to the reference product adalimumab (Humira), a tumor necrosis factor alpha (TNFα) inhibitor monoclonal antibody. Developed by Alvotech, it demonstrates physicochemical, pharmacokinetic, efficacy, safety, and immunogenicity similarity to adalimumab in healthy subjects and patients with moderate-to-severe chronic plaque psoriasis, including after switching. It is approved in the EU (as Hukyndra), Canada (as Simlandi), Australia (as Ciptunec/Ardalicip), UK, Switzerland, Norway, Iceland, Liechtenstein, and Saudi Arabia for all adalimumab indications, such as rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, Crohn's disease, ulcerative colitis, psoriasis, and uveitis; US FDA approval was granted as Simlandi (adalimumab-ryvk) with interchangeable status.[1][2][5][7][9]

Brand names
HukyndraLibmyrisSimlandiCiptunecArdalicip
Other names
Humira biosimilaradalimumab biosimilar
02

Targets

C1Q (Complement C1q)FcγR (Low affinity immunoglobulin gamma Fc region receptor II-c)TNFA (Tumor necrosis factor alpha (soluble))

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