First Patient Enrolled in Phase 3 Study Evaluating HUMIRA Biosmilar

Mar 15, 2019 | Adalimumab, Autoimmune Disease, Biosimilars, Humira

Alvotech, whose drug candidate AVT02 is being developed as a biosimilar to adalimumab (Humira, AbbVie), enrolled the first patient in a clinical phase 3 study evaluating the product, the company recently announced in a press release. Adalimumab, a tumor necrosis factor inhibitor (TNF), is indicated for the treatment of autoimmune diseases such as rheumatoid arthritis, juvenile idiopathic arthritis, psoriatic arthritis, ankylosing spondylitis, Crohn disease, and plaque psoriasis.

Adalimumab targets and blocks the TNF protein that contributes to the disease symptoms of autoimmune conditions, such as inflammation and tissue destruction. AVT02’s formulation contains a high concentration (100 mg/ml) of adalimumab, which is expected to be more convenient for patients compared with other biosimilar products, according to Alvotech. The objective of the phase 3 study is to compare AVT02 with adalimumab in terms of safety, efficacy, tolerability, and immunogenicity in adult patients with moderate-to-severe chronic plaque psoriasis. According to Alvotech, the study will enroll 400 participants at approximately 30 sites across Europe.
Two of the lead investigators are included below.

Lead Research/Investigator

Jaak Talli, MD, Innomedical OU

Steven Feldman, MD, Phd, Wake Forest University Health Sciences


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