Alvotech Advances Vedolizumab Biosimilar Program with FDA BLA Acceptance for Subcutaneous AVT80 — Alvotech

Event summary

FDA accepted Alvotech's BLA for AVT80, a proposed interchangeable biosimilar to Entyvio® for subcutaneous administration.
AVT80 complements AVT16, Alvotech's intravenous biosimilar to Entyvio, which had its BLA accepted in May 2026.
The BLA submission includes analytical, pharmacokinetic, and immunogenicity data from a pivotal study completed in February 2026.
Alvotech partners with Teva for commercialization, while handling development and manufacturing.
If approved, AVT80 would expand biosimilar options for ulcerative colitis and Crohn’s disease treatments.

The big picture

Alvotech's FDA BLA acceptance for AVT80 marks another step in its strategy to expand biosimilar offerings in immunology, competing with Entyvio in both intravenous and subcutaneous forms. The partnership with Teva underscores a common model in biotech, where development and commercialization are split to optimize expertise. Success here could set a precedent for Alvotech's ability to navigate complex regulatory pathways and bring cost-effective treatments to market.

What we're watching

Regulatory Approval: The pace at which the FDA reviews and potentially approves AVT80 will determine its market entry timeline.
Commercial Strategy: How Teva leverages its commercialization expertise to position AVT80 against Entyvio in the U.S. market.
Pipeline Expansion: Whether Alvotech can sustain momentum in its broader biosimilar pipeline beyond vedolizumab.