Alvotech wins FDA review acceptance for AVT80 vedolizumab biosimilar

Alvotech has secured FDA acceptance for review of its Biologics License Application for AVT80, a proposed interchangeable biosimilar to Takeda's Entyvio (vedolizumab) in prefilled syringe and autoinjector formats for subcutaneous administration. The milestone, announced on 31 August 2026, follows the FDA's acceptance of a separate BLA for AVT16, Alvotech's intravenous vedolizumab biosimilar, in May this year.

Together, AVT16 and AVT80 form a matched programme intended to mirror the full approved presentation set of the reference product. Entyvio is indicated for adults with moderately to severely active ulcerative colitis and Crohn's disease, conditions that affect millions of patients globally and represent a combined market worth several billion dollars annually. Commercialisation in the United States is handled by Teva Pharmaceutical Industries under an existing partnership, with Alvotech retaining responsibility for development and manufacture.

The data package

The AVT80 BLA is supported by analytical, pharmacokinetic, and immunogenicity data. A pivotal pharmacokinetic study reported positive results in February 2026: the randomised, double-blind, single-dose, three-arm parallel-group study compared AVT80 against the reference product in healthy adult participants and met all primary endpoints. The FDA and Alvotech have agreed that this single study is considered pivotal to support clinical similarity claims for both the subcutaneous and intravenous candidates, a regulatory alignment that streamlines the evidentiary burden across the programme.

Alvotech is pursuing interchangeable status for AVT80, the higher designation under US biosimilar regulations. Interchangeable biosimilars may be substituted at the pharmacy without prescriber intervention, subject to state law, a distinction that materially affects uptake rates compared with biosimilars approved only for substitution with a prescription.

Joseph McClellan, chief operating officer of Alvotech, said the acceptance was "another important milestone" for the vedolizumab programme and highlighted that the combined BLA filings now span intravenous and subcutaneous routes as well as two device formats.

In the European Union, the European Medicines Agency has already validated a Marketing Authorisation Application covering both candidates, giving Alvotech a parallel regulatory track across major markets.

Market context and competitive positioning

The vedolizumab biosimilar space is increasingly crowded. Several manufacturers have signalled interest in the reference product, whose originator exclusivities in major markets have expired or are expiring in the near term. Vedolizumab's gut-selective mechanism, acting on the alpha-4-beta-7 integrin to reduce white blood cell migration into gastrointestinal tissue, differentiates it from systemic immunosuppressants, and clinicians treating inflammatory bowel disease have shown strong interest in retaining patient access to the class at lower cost.

Alvotech's strategy of pursuing interchangeability across both presentations is relatively ambitious: most early biosimilar entrants to a class seek approval first, then pursue interchangeability in a supplemental application. Securing interchangeable status from the outset, if granted, would give AVT80 a structural pharmacy-access advantage that a non-interchangeable competitor cannot easily replicate without its own additional study work.

Alvotech already holds five approved and marketed biosimilars globally, referencing adalimumab, ustekinumab, golimumab, aflibercept and denosumab. The company's fully integrated manufacturing model, based out of Reykjavik, is a recurring differentiator cited in investor materials, though investors will be watching the PDUFA timeline for AVT16 as the leading indicator of the agency's appetite for Alvotech's vedolizumab data package before AVT80 reaches its own action date.