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Alvotech Announces Positive Phase 1 Results for Ustekinumab Biosimilar


In a pharmacokinetic study, Alvotech’s ustekinumab biosimilar referencing Stelara was shown to have comparable safety and efficacy to the reference product, according to the company’s preliminary results.

Alvotech shared positive results from its pharmacokinetics similarity study for its ustekinumab biosimilar candidate (AVT04) and the reference product (Stelara).

“We are pleased with the successful outcome of the AVT04 [pharmacokinetics] similarity study and the continued progress of our overall pipeline. We expect the results from our confirmatory efficacy and safety study for AVT04 before the end of the 2nd quarter,” said Joseph McClellan, chief scientific officer at Alvotech, in a company statement.

The 3-arm, single dose, parallel design phase 1 study (AVT04-GL-101) was conducted to assess the pharmacokinetics, safety, tolerability, and immunogenicity profiles of a 45-mg/0.5-mL subcutaneous dose of the biosimilar compared with Stelara, which is approved for use in the United States and the European Union. There were 294 healthy adult volunteers enrolled from Australia and New Zealand.

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.

According to Johnson & Johnson’s 2021 financial report, Stelara accounted for over $9.1 billion in total sales, $5.9 billion of which were from the United States.

Bio-Thera Solutions and Hikma Pharmaceuticals, Amgen, BioFactura, Dong-A ST and Meiji Seika Pharma, Neuclone, and Samsung Bioepis are all working on developing their own ustekinumab biosimilars. Formycon recently signed a deal with ATHOS to acquire assets for its own ustekinumab biosimilar candidate.

In addition to AVT04, Alvotech’s adalimumab biosimilar (AVT02) is currently under review with the FDA for both regulatory approval and interchangeability status in the United States. The product, which references Humira, is also approved in Canada and is awaiting launch and has received marketing authorization status from the European Commission.

Other biosimilars that Alvotech is in the process of developing include an omalizumab candidate (AVT23), a denosumab candidate (AVT03), a golimumab candidate (AVT05), an aflibercept biosimilar (AVT06), and 2 undisclosed molecules (AVT16 and AVT33). AVT23 will reference Xolair, AVT03 will reference Prolia/Xgeva, AVT05 is a biosimilar to Simponi, and AVT06 will reference Eylea.

“We are delighted at the continued progress of our pipeline of biosimilar candidates. This continued progress demonstrates the strength of Alvotech’s purpose-built biosimilar platform,” said Róbert Wessman, founder and chairman at Alvotech.

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