Alvotech’s golimumab biosimilar phase 1 trial begins

Alvotech has announced that it has begun a phase 1 study evaluating the safety, tolerability and pharmacokinetics of its golimumab biosimilar candidate (AVT05). Patients have already started being dosed in the trial.

AVT05 was developed as a biosimilar for Simponi and Simponi Aria, used in combination with methotrexate to treat rheumatoid arthritis, and alone to treat psoriatic arthritis, ankylosing spondylitis and polyarticular juvenile idiopathic arthritis. Simponi is administered subcutaneously and can be used in adult patients, while Simponi Aria is administered intravenously and can be used in both adult and paediatric patients aged two years and older.

Alvotech’s biosimilar portfolio already comprises eight products to treat various autoimmune diseases, retinal disorders, osteoporosis, respiratory diseases and certain cancers. For example, AVT04, currently under FDA review, is an adalimumab candidate which referenced Humira. AVT04 is expected to become available on US markets in July 2023.

The company is also awaiting FDA approval on various other candidates, and is in the process of completing a phase 1 trial for a denosumab biosimilar candidate, as well as having begun a phase 3 trial for an aflibercept biosimilar in July 2022.

Joseph McClellan, PhD, chief scientific officer at Alvotech, commented: “We are delighted with the progress of the AVT05 development programme… As we enter our fifth biosimilar candidate into clinical studies, we reaffirm our commitment to improving patient lives by expanding access to affordable biologics.”

Alongside Alvotech, Bio-Thera solutions is also working on a golimumab biosimilar candidate (BAT2506), which is being assessed in a phase 3 trial of 480 psoriatic arthritis patients.

Betsy Goodfellow