Alvotech Advances Vedolizumab Biosimilar Program with FDA BLA Acceptance for Subcutaneous AVT80
Event summary
- FDA accepted Alvotech's BLA for AVT80, a proposed interchangeable biosimilar to Entyvio® for subcutaneous administration.
- AVT80 complements AVT16, Alvotech’s proposed interchangeable biosimilar to Entyvio for intravenous administration, which was accepted for review in May 2026.
- The BLA submission is supported by comprehensive data, including analytical, pharmacokinetic, and immunogenicity data.
- AVT80 has been submitted as a proposed interchangeable biosimilar, which may be substituted for the reference product at the pharmacy without prescriber intervention if approved.
The big picture
Alvotech’s FDA BLA acceptance for AVT80 marks another step in its strategy to expand access to biosimilar treatments for inflammatory bowel diseases. The company’s partnership with Teva underscores a broader trend of biotech firms collaborating to navigate regulatory hurdles and commercialize complex biologics. Success here could position Alvotech as a key player in the biosimilar space, particularly in immunology.
What we're watching
- Regulatory Approval
- Whether AVT80 will secure FDA approval and become interchangeable with Entyvio®, expanding treatment options for ulcerative colitis and Crohn’s disease.
- Market Competition
- How Alvotech and Teva will position AVT80 against Entyvio® and other biosimilars in the U.S. market.
- Commercial Strategy
- The pace at which Alvotech and Teva can commercialize AVT80 and AVT16, leveraging their global partnership network.
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