New Data Show Bioequivalence for Alvotech Stelara Biosimilar

AVT04, an ustekinumab biosimilar candidate developed by Alvotech, has proven to have clinically equivalent safety, efficacy, and immunogenicity profiles as the reference product (Stelara), according to results from Alvotech’s confirmatory clinical trial.

The news comes shortly after the company published results from a pharmacokinetics similarity study for AVT04 in early May 2022. Teva Pharmaceuticals is the exclusive strategic partner for US commercialization of AVT04, and STADA Arzneimittel will market the biosimilar in the European markets.

Alvotech is the second company to announced positive clinical efficacy study results for a ustekinumab biosimilar candidate, following Amgen’s phase 3 results, which were released in April 2022.

“Completing this clinical milestone, less than one year since we recruited the first subject, truly demonstrates the success of our clinical development and integrated approach to rapidly advancing multiple high-quality biosimilar candidates,” said Robert Wessman, founder and chairman of Alvotech, in a company statement.

The randomized, double-blind, multicenter study (AVT04-GL-301) tested the drugs in 581 patients with moderate-to-severe plaque psoriasis. According to Alvotech, the study met its primary endpoint demonstrating therapeutic equivalence between the biosimilar and reference product and no clinically meaningful safety differences were observed through 28 weeks. The primary endpoint was improvement in patients’ psoriasis area and severity index percentage from baseline through week 12.

The secondary endpoints included improvements in quality-of-life scores as well as similar safety, immunogenicity, tolerability, and pharmacokinetics.

Ustekinumab is a humanized immunoglobulin G1k (IgG1k) monoclonal antibody used to treat psoriatic arthritis, Crohn disease, ulcerative colitis, and plaque psoriasis. IgG1k antibodies bind to the p40 protein subunit utilized by interleukin (IL)-12 and IL-23 cytokines.

Currently, Alvotech has 8 biosimilars in its portfolio, including AVT04 and AVT02, its biosimilar referencing Humira (adalimumab). Approval for AVT02 is under review in the United States and granted in the European Union, the United Kingdom, Switzerland, Norway, Iceland, Lichtenstein and Canada.

Alvotech’s sole focus on biosimilar development allows the company to have a higher sustainability profile compared with other biopharmaceutical companies largely due to the nature of developing biologic drugs and because the company is based in Iceland, a country revered for its large investment in renewable energy sources.