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.
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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.
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
Investment Themes
Documents Analyzed
This report is based on 1 press release from GlobeNewswire.
| Document | Accession Number |
|---|---|
| PRESS-RELEASE Data (Synthetic) | press-3307835 |
Filters
| Type | Now | ||||
|---|---|---|---|---|---|
Oct 20, 2026 6d ago | 6-K | $5.12 | awaiting T+20 | — | $4.62 (−9.77%) |
Oct 14, 2026 12d ago | 6-K | $5.17 | awaiting T+20 | — | $4.62 (−10.64%) |
Oct 7, 2026 19d ago | 6-K | $5.85 | awaiting T+20 | — | $4.62 (−21.03%) |
Oct 5, 2026 21d ago | 6-K | $6.11 | awaiting T+20 | — | $4.62 (−24.39%) |
Oct 5, 2026 22d ago | Press Release | $6.11 | awaiting T+20 | — | $4.62 (−24.39%) |
Aug 31, 2026 8w ago | 6-K | $5.19 $5.92 | ▲ +14.07% | ▲ +14.44% | $4.62 (−10.98%) |
Aug 21, 2026 9w ago | 6-K | $4.43 $5.88 | ▲ +32.73% | ▲ +31.72% | $4.62 (+4.29%) |
Aug 19, 2026 9w ago | Press Release | $4.27 $5.87 | ▼ −37.47% | ▼ −37.59% | $4.62 (−8.20%) |
Jul 29, 2026 12w ago | 6-K | $3.53 $4.91 | ▲ +39.09% | ▲ +34.07% | $4.62 (+30.88%) |
Jul 3, 2026 16w ago | Press Release | $3.46 $4.12 | ▲ +19.08% | ▲ +19.64% | $4.62 (+33.53%) |
US Market Status
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