Alvotech wins FDA review acceptance for AVT16 vedolizumab biosimilar

Alvotech has announced that the US Food and Drug Administration has accepted for review its Biologics License Application for AVT16, a proposed interchangeable biosimilar to Entyvio (vedolizumab). The candidate targets the same indication as the reference product: moderately to severely active ulcerative colitis and Crohn's disease in adults.

Under the terms of Alvotech's commercial arrangement with Teva Pharmaceutical Industries, Alvotech retains responsibility for development and manufacturing of AVT16, while Teva will handle commercialisation in the United States. The partnership structure mirrors several other biosimilar deals in which a manufacturing-focused developer pairs with a large commercial organisation to reach patients at scale.

The data package

The BLA is supported by analytical, pharmacokinetic, and immunogenicity data assembled to demonstrate biosimilarity between AVT16 and the reference product. Alvotech also noted that a pivotal pharmacokinetic study completed in February 2026 for AVT80 — its proposed subcutaneous formulation of vedolizumab — met all primary endpoints. Regulatory guidance has designated that study as pivotal for both the intravenous AVT16 and the subcutaneous AVT80 programmes, effectively providing a shared clinical evidence base for the two candidates.

Joseph McClellan, Chief Operating Officer of Alvotech, said the BLA acceptance "builds on our experience in immunology and reflects the strength of our fully integrated development and manufacturing platform."

The interchangeable designation is commercially significant. In the United States, an interchangeable biosimilar may be substituted at the pharmacy counter without prescriber intervention, subject to state-level pharmacy laws — a distinction that typically translates into stronger uptake relative to non-interchangeable biosimilars, which require an active prescriber switch.

Market context

Vedolizumab is a high-value target in the biosimilar landscape. Entyvio, marketed by Takeda, generated global revenues exceeding $5 billion annually in recent years, and the inflammatory bowel disease category — which spans ulcerative colitis and Crohn's disease — remains one of the fastest-growing segments in gastroenterology-focused biologics.

The IBD biosimilar space is becoming increasingly competitive. Samsung Bioepis and Celltrion have both disclosed vedolizumab biosimilar programmes at various stages of development, and the FDA's track record of approving interchangeable biosimilars in immunology — including multiple adalimumab designations — suggests the agency is comfortable with the regulatory pathway. Alvotech already holds approved biosimilars to five reference products, including adalimumab and ustekinumab, lending its manufacturing platform credibility with regulators and payers alike.

The European Medicines Agency has separately validated a Marketing Authorisation Application covering both AVT16 and AVT80, meaning Alvotech is pursuing parallel regulatory tracks across the two largest biologic markets. Neither product has received approval in any market to date. The PDUFA action date for the US review has not been disclosed in the announcement, and investors will watch for that milestone as the clearest near-term signal on commercialisation timing.