Alvotech has announced positive top-line results from a pharmacokinetic (PK) study for AVT80, a biosimilar candidate to Entyvio (vedolizumab).

The PK study (AVT80-GL-P01), which compared AVT80 to Entyvio in healthy adult participants, met all its primary endpoints. This was a randomised, double-blind, single dose, parallel-group design, 3-arm study, designed to demonstrate the PK similarity, and to investigate safety, tolerability and immunogenicity profiles of AVT80 and Entyvio in healthy adult participants after administration of a single 108 mg/0.68 mL subcutaneous (SC) injection.

“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, Alvotech.

The company is currently developing AVT16, a proposed biosimilar to Entyvio for intravenous administration and AVT80, a proposed biosimilar to Entyvio for subcutaneous administration. The AVT80-GL-P01 study satisfies the demonstration of PK similarity for both the subcutaneous and intravenous routes of administration to Entyvio. Based on regulatory advice, the AVT80-GL-P01 clinical study is considered pivotal to support the demonstration of clinical similarity for AVT16 and AVT80.

Entyvio (vedolizumab) is indicated for the treatment of adult patients with moderate-to-severe Ulcerative Colitis, a disease that causes inflammation and ulcers in the lining of the bowel, and moderate-to-severely active Crohn’s disease, a disease that causes inflammation of the digestive tract.