ALVO Alvotech
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Executive Summary
Alvotech announced FDA acceptance of its BLA for AVT16, a proposed interchangeable biosimilar to Entyvio (vedolizumab) for IV use in ulcerative colitis and Crohn's disease. This is a procedural milestone—acceptance for review does not guarantee approval—but it advances a key pipeline asset partnered with Teva. The filing also notes positive Phase 1 data for AVT80 (subcutaneous Entyvio biosimilar) from February 2026, which supports both candidates.
Actionable Insight
Monitor FDA review timeline (typically 10-12 months from acceptance) and any AdCom vote. Approval of AVT16 would add a second interchangeable biosimilar to Alvotech's U.S. portfolio and could generate meaningful revenue via Teva partnership. The February 2026 AVT80 PK data is a positive cross-supporting signal.
Key Facts
- FDA accepted for review the BLA for AVT16, a proposed interchangeable biosimilar to Entyvio (vedolizumab) for IV administration.
- Alvotech is responsible for development and manufacturing; Teva is responsible for commercialization in the U.S.
- AVT16 targets moderately to severely active ulcerative colitis and Crohn's disease in adults.
- In February 2026, Alvotech reported positive pivotal PK study results for AVT80 (subcutaneous Entyvio biosimilar), which also supports AVT16's clinical similarity package.
- AVT16 and AVT80 are investigational and have not received regulatory approval in any market.
- Alvotech has five approved biosimilars on the market and a pipeline of nine disclosed candidates.
Financial Impact
No financial terms disclosed; BLA acceptance is procedural with no immediate revenue impact. Entyvio had U.S. sales of approximately $5.5B in 2025 (not stated in filing, for context only).
Risk Factors
- FDA may issue a Complete Response Letter (CRL) on safety, efficacy, or CMC grounds, delaying or denying approval.
- Entyvio faces competition from other biosimilars (e.g., Celltrion, Samsung Bioepis) that could erode market opportunity.
- Interchangeability designation is not guaranteed and requires additional data; without it, market uptake may be slower.
- Alvotech has a history of FDA manufacturing deficiencies (not stated in filing, but known from prior context).
Market Snapshot
Documents Analyzed
This report is based on 1 press release from GlobeNewswire.
| Document | Accession Number |
|---|---|
| PRESS-RELEASE Data (Synthetic) | press-3307832 |
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Jun 8, 2026
1d ago
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Press Release
| $3.55 awaiting T+1 | awaiting T+1 | — | $4.24 (+19.61%) |
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Jun 8, 2026
1d ago
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Press Release
| $3.55 awaiting T+1 | awaiting T+1 | — | $4.24 (+19.61%) |
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Jun 4, 2026
5d ago
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Press Release
| $3.74 $3.54 | ▼ −5.35% | ▼ −2.75% | $4.24 (+13.37%) |
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May 11, 2026
29d ago
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Press Release
| $3.59 $3.55 | ▼ −1.11% | ▼ −0.98% | $4.24 (+18.11%) |
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May 11, 2026
29d ago
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Press Release
| $3.59 $3.55 | ▼ −1.11% | ▼ −0.98% | $4.24 (+18.11%) |
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May 6, 2026
4w ago
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Press Release
| $3.20 $3.20 | · 0.00% | ▲ +0.83% | $4.24 (−32.50%) |
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May 6, 2026
4w ago
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Press Release
| $3.20 $3.20 | · 0.00% | ▲ +0.83% | $4.24 (−32.50%) |
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Apr 24, 2026
6w ago
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Press Release
| $3.38 $3.30 | ▼ −2.37% | ▼ −2.53% | $4.24 (+25.44%) |
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Apr 24, 2026
6w ago
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Press Release
| $3.38 $3.30 | ▼ −2.37% | ▼ −2.53% | $4.24 (+25.44%) |
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Mar 4, 2026
13w ago
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Press Release
| $3.89 $4.16 | ▲ +6.94% | ▲ +7.51% | $4.24 (+9.00%) |
US Market Status
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