Alvotech (NASDAQ:ALVO) reported positive findings from a pharmacokinetic trial evaluating AVT80, its experimental biosimilar to Entyvio, after the study successfully achieved all primary objectives. The randomized, double-blind trial compared AVT80 with Entyvio in healthy adult volunteers who received a single 108 mg subcutaneous dose.
The research examined pharmacokinetics, safety, tolerability and immunogenic response of AVT80 relative to the reference product. Based on the outcome, the company said the data supports continued progress toward regulatory filing for the biosimilar candidate.
Alvotech is currently developing two potential biosimilars to Entyvio: AVT16, designed for intravenous delivery, and AVT80, intended for subcutaneous use. The company noted that the study demonstrates pharmacokinetic comparability for both delivery formats and represents a key milestone in confirming clinical similarity for the two programs.
Entyvio, produced by Takeda, is used to treat adult patients with moderate-to-severe ulcerative colitis and Crohn’s disease. According to company information, the treatment generated around $6.4 billion in global net sales during 2025.
Headquartered in Iceland, Alvotech focuses on the development and production of biosimilar therapies. The company has already secured regulatory approvals for two biosimilars referencing Humira and Stelara across several international markets.
Both AVT16 and AVT80 contain vedolizumab, a human monoclonal antibody designed to target the alpha-4-beta-7 protein found on T helper lymphocytes. The two treatments remain under investigation and have not yet been approved by regulatory authorities in any jurisdiction.