ALVO Alvotech
Price Chart
Executive Summary
Alvotech announced FDA acceptance of its BLA for AVT16, a proposed interchangeable biosimilar to Entyvio (vedolizumab), for intravenous administration. This is a procedural milestone that advances the regulatory review process but does not guarantee approval. The filing is supported by a comprehensive data package and follows positive Phase 1 PK results for AVT80, the subcutaneous formulation.
Actionable Insight
FDA acceptance for review is a routine procedural step — it does not change the probability of approval. Monitor for an FDA action date (typically 10-12 months from acceptance) and any AdCom vote. The AVT80 PK data provides some cross-support, but the key catalyst remains the FDA decision on AVT16.
Key Facts
- FDA accepted for review the BLA for AVT16, a proposed interchangeable biosimilar to Entyvio (vedolizumab) lyophilized vial for IV use.
- Alvotech is responsible for development and manufacturing; Teva is responsible for commercialization under a partnership.
- The BLA submission is supported by analytical, pharmacokinetic, and immunogenicity data to demonstrate biosimilarity.
- AVT16 has been submitted as a proposed interchangeable biosimilar, which could allow pharmacy-level substitution if approved.
- In February 2026, Alvotech reported positive pivotal PK study results for AVT80 (subcutaneous Entyvio biosimilar), which also supports AVT16.
- AVT16 and AVT80 are investigational and have not received regulatory approval in any market.
Financial Impact
No financial terms disclosed; deal value not stated.
Risk Factors
- FDA may issue a Complete Response Letter (CRL) citing safety, efficacy, or manufacturing deficiencies.
- Biosimilar interchangeability designation is not guaranteed and requires additional data.
- Entyvio faces competition from other biosimilars and novel therapies in IBD.
Market Snapshot
Documents Analyzed
This report is based on 1 press release from GlobeNewswire.
| Document | Accession Number |
|---|---|
| PRESS-RELEASE Data (Synthetic) | press-3307835 |
Filters
| Type | Now | ||||
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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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