Alvotech (ALVO) has reported that its pivotal pharmacokinetic study for AVT80- its proposed biosimilar to Takeda Pharma's Entyvio - met all primary endpoints, marking a key milestone in the company's dual-formulation vedolizumab program.
Entyvio is indicated for the treatment of Ulcerative Colitis and Crohn's disease, two chronic inflammatory bowel diseases that often require long-term biologic therapy. With global Entyvio sales reaching $6.4 billion in 2025, biosimilar competition is expected to play a significant role in expanding patient access and reducing treatment costs.
The pivotal pharmacokinetic (PK) study, AVT80-GL-P01, was a randomized, double-blind, single-dose trial conducted in healthy adults. It compared AVT80 with the reference product and demonstrated pharmacokinetic similarity, supported by aligned safety, tolerability, and immunogenicity profiles. These results form the core clinical requirement for biosimilar approval in major regulatory markets.
Alvotech is developing two Vedolizumab biosimilar candidates:
•AVT16 for intravenous administration
•AVT80 for subcutaneous administration
Regulators allow a single PK study to support both formulations when justified analytically- a strategy Alvotech is pursuing to streamline development.
The company emphasized that the positive results strengthen its vertically integrated biosimilar platform, which spans cell line development, manufacturing, analytics, and clinical execution. With multiple biosimilars already approved or under review globally, Alvotech continues to expand its pipeline across autoimmune diseases, ophthalmology, osteoporosis, respiratory conditions, and oncology.
Upcoming Milestones Across Alvotech's Pipeline
•Continued regulatory submissions for AVT16 and AVT80 based on PK similarity data.
•Ongoing development of biosimilars targeting high-value biologics in immunology and oncology.
•Expansion of global commercialization partnerships across the U.S., Europe, and Asia.
ALVO had traded between $4.32 and $13.08 over the past year. The stock closed yesterday's trading at $5.09, down 2.30% and is currently trading in the pre-market at $5.36, up 5.30%.
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