Alvotech Posts Positive Pharmacokinetic Data For AVT80 Study Supports Clinical Similarity For SC And IV Vedolizumab Biosimilars, Advancing Entyvio Biosimilar Program

Alvotech reported positive top-line results from a pharmacokinetic study evaluating AVT80, its proposed biosimilar to Entyvio (vedolizumab). The randomized, double-blind, three-arm trial in healthy adults met all primary endpoints, showing pharmacokinetic similarity between AVT80 and the reference drug after a single subcutaneous dose. The study also assessed safety, tolerability, and immunogenicity, supporting AVT80’s comparability profile.

The AVT80-GL-P01 trial was designed to compare both subcutaneous and intravenous exposure to Entyvio, making it pivotal for Alvotech’s broader biosimilar program. In addition to AVT80 for subcutaneous use, the company is developing AVT16 as an intravenous biosimilar version of the same originator product. Regulatory guidance indicates that the PK data from this study can underpin clinical similarity for both candidates.

“We are very pleased with this result, which is an important milestone in the development of our proposed biosimilar to Entyvio, allowing us to proceed towards regulatory submissions. This milestone further underlines the strength of our platform approach to biosimilars development and manufacture, combining a well-designed and executed clinical study with the design of a high-quality manufacturing process and strong analytical capabilities,” said Joseph McClellan, Chief Operating Officer.

Entyvio is approved for adults with moderate to severe ulcerative colitis and Crohn’s disease, two chronic inflammatory bowel conditions. The brand generated approximately $6.4 billion in global revenue in 2025, underscoring the commercial importance of biosimilar competition in this space.