Alvotech's Biosimilar Candidate AVT80 Meets Key Endpoints in Pivotal Study
Event summary
- Alvotech's AVT80, a biosimilar candidate to Entyvio®, met all primary endpoints in a pivotal pharmacokinetic study.
- The study was a randomized, double-blind, single-dose, parallel-group design involving healthy adult participants.
- AVT80 is intended for subcutaneous administration, while AVT16 is for intravenous administration, both targeting Entyvio®.
- Entyvio® generated approximately $6.4 billion in global revenues in 2025.
- Alvotech plans to proceed with regulatory submissions based on these results.
The big picture
Alvotech’s successful pharmacokinetic study for AVT80 is a critical step in its strategy to capture a share of the lucrative biosimilar market for Entyvio®. The company’s fully integrated approach and broad in-house capabilities position it to compete with established players like Takeda. The global reach of its commercial partnerships will be key to scaling these products across multiple regions.
What we're watching
- Regulatory Pathway
- The pace at which Alvotech advances AVT80 and AVT16 through regulatory approvals will determine market entry timelines.
- Market Competition
- How Alvotech positions AVT80 and AVT16 against Entyvio® in the $6.4 billion market for ulcerative colitis and Crohn’s disease treatments.
- Partnership Strategy
- Whether Alvotech’s extensive network of commercial partners can effectively launch and scale these biosimilars globally.
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