Alvotech (NASDAQ:ALVO) announced positive top-line results from a pivotal clinical study for its biosimilar candidate to Entyvio, positioning the Icelandic biotech to challenge one of the top-selling gastrointestinal treatments in a $6.4 billion market.
The Reykjavik-based company reported on Thursday that its pharmacokinetic (PK) study, AVT80-GL-P01, met all primary endpoints, demonstrating similarity between its candidate, AVT80, and the reference biologic, Entyvio (vedolizumab).
The randomized, double-blind trial conducted in healthy adults confirmed that AVT80 matches the safety, tolerability, and immunogenicity profile of the original drug.
Critically, Alvotech noted that this single study is sufficient to support regulatory filings for both the subcutaneous (AVT80) and intravenous (AVT16) versions of the therapy.
The milestone is a significant step for Alvotech’s strategy of targeting high-value biologics as they lose patent protection.
Entyvio, marketed by Takeda Pharmaceutical, generated approximately $6.4 billion in global net sales in 2025, serving as a standard of care for moderate-to-severe ulcerative colitis and Crohn’s disease.