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Phase 1 Trial for Alvotech Golimumab Biosimilar Begins


Alvotech announced that a phase 1 pharmacokinetic study for its golimumab biosimilar referencing Simponi has commenced.

Alvotech announced that it has begun dosing healthy participants with its golimumab biosimilar candidate (AVT05) as part of its phase 1 study evaluating the drug’s safety, pharmacokinetics, and tolerability.

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

AVT05 was developed to reference Simoni and Simponi Aria, which are used to treat rheumatoid arthritis in combination with methotrexate, psoriatic arthritis, ankylosing spondylitis, and polyarticular juvenile idiopathic arthritis. Simponi is administrated subcutaneously and Simponi Aria is administered intravenously. Simponi can be used in adult patients and Simponi Ara can be prescribed for adult and pediatric patients 2 years or older.

From October 2021 to October 2022, global combined net revenues for Simponi and Simponi Aria reached over $2.2 billion, according to reported sales data from Johnson & Johnson, the manufacturer of the reference products.

Alvotech’s biosimilar portfolio contains 8 products that can be used to treat autoimmune diseases, retinal disorders, osteoporosis, respiratory diseases, and several cancers. AVT04, an adalimumab candidate referencing Humira, is currently under review with the FDA and is expected to launch on the US market in July 2023. The company and its partner STADA Arzneimittel have launched AVT04 in several European markets. AVT04 is also approved in Australia.

In addition, Alvotech submitted a biologics license application for an ustekinumab biosimilar referencing Stelara to the FDA. A phase 1 trial is in progress for a denosumab biosimilar candidate referencing Xgeva/Prolia. In July 2022, Alvotech initiated a phase 3 trial for an aflibercept biosimilar referencing Eylea.

In February 2022, Alvotech entered into a licensing agreement with BiosanaPharma for the development of a biosimilar for Xolair (omalizumab). AVT16 and AVT33 are the other products in development; however, the molecules they are referencing have not been disclosed publicly.

In June 2022, Alvotech became a publicly traded corporation on the Nasdaq stock market, making it the first dual-listed Islandic company to be on both a US and Icelandic stock exchange.

In addition to Alvotech, Bio-Thera Solutions is working on its own golimumab biosimilar candidate (BAT2506). The biosimilar is currently being evaluated in a phase 3 trial of 480 patients with psoriatic arthritis.

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