Alvotech Scores Second FDA BLA Acceptance in Four Months — AVT80 Subcutaneous Vedolizumab Biosimilar Now Under Review

Alvotech (ALVO) picked up its second FDA filing win of 2026 on August 31, when the agency accepted for review a Biologics License Application for AVT80, a proposed interchangeable biosimilar to Entyvio (vedolizumab) in both prefilled syringe and autoinjector forms for subcutaneous administration.

The move pairs with the FDA's May 2026 acceptance of AVT16, Alvotech's proposed interchangeable biosimilar to the same reference product for intravenous administration. Together, the two candidates cover both delivery routes for vedolizumab, and both carry the interchangeable designation — meaning, if approved, either could be substituted at the pharmacy without prescriber intervention, subject to applicable state laws.

Chief Operating Officer Joseph McClellan called the development "another important milestone for our vedolizumab biosimilar program" in Alvotech's August 31 news release on GlobeNewswire.

The clinical foundation for the BLA submission was established in February 2026, when Alvotech announced positive results from a pivotal pharmacokinetic study for AVT80. The randomized, double-blind, single-dose, parallel-group, three-arm study compared AVT80 to Entyvio in healthy adult participants and met all its primary endpoints.

Under Alvotech's partnership with Teva Pharmaceutical Industries Ltd., Alvotech handles development and manufacturing while Teva carries the commercialization responsibility in the United States.

AVT80 and AVT16 remain investigational products and have not received regulatory approval in any market.

On the balance sheet, Alvotech has been active. As of August 21, 2026, the company reported 338.22 million shares outstanding and a market cap of $1.64 billion at a share price of $4.42. That same week, Alvotech signed a licensing and commercialization agreement with Lotus Pharmaceutical valued at up to approximately $150 million, raised approximately $165 million through an equity offering and private placement, and drew a new $75 million term loan — a significant liquidity build ahead of what could be a pivotal regulatory stretch.

The back-to-back BLA acceptances make Alvotech's vedolizumab program one to watch in the biosimilar pipeline. What's next, per the company's public disclosures, is FDA review of both filings — AVT16 accepted in May 2026 and AVT80 accepted August 31, 2026 — with no approval dates yet disclosed.