Alvotech announces FDA acceptance of Biologics License Application for AVT16, a proposed interchangeable biosimilar to Entyvio®
Rhea-AI Summary
Alvotech (NASDAQ: ALVO) announced FDA acceptance for review of its Biologics License Application for AVT16, a proposed interchangeable biosimilar to Entyvio (vedolizumab) IV. Under its partnership with Teva, Alvotech handles development and manufacturing, while Teva leads commercialization.
The BLA is backed by analytical, pharmacokinetic and immunogenicity data to support biosimilarity. AVT16 targets adults with moderately to severely active ulcerative colitis and Crohn’s disease. A pivotal pharmacokinetic study of AVT80, another Entyvio biosimilar candidate, met all primary endpoints and supports clinical similarity for both AVT16 and AVT80.
Positive
- FDA accepts BLA for AVT16, proposed interchangeable Entyvio biosimilar
- Teva partnership splits roles: Alvotech develops and manufactures, Teva commercializes
- BLA supported by analytical, pharmacokinetic and immunogenicity data package
- AVT80 pivotal pharmacokinetic study met all primary endpoints
- Regulatory advice deems AVT80 study pivotal for AVT16 and AVT80 similarity
Negative
- None.
News Market Reaction – ALVO
In the Jun 8 session, ALVO gained 19.77%, reflecting a significant positive market reaction. Argus tracked a peak move of +21.4% during that session. Our momentum scanner triggered 31 alerts that day, indicating elevated trading interest and price volatility. Trading volume was very high at 3.1x the daily average, suggesting strong buying interest.
Data tracked by StockTitan Argus on the day of publication.
Key Figures
Historical Context
| Date | Event | Sentiment | 24h Move | Catalyst |
|---|---|---|---|---|
| Jun 04 | BLA resubmissions | Positive | +19.1% | Resubmission of AVT05 and AVT06 BLAs after addressing FDA feedback. |
| Jun 03 | AGM outcomes | Positive | +19.1% | All resolutions approved at 2026 AGM and EGM in Luxembourg. |
| Jun 02 | Investor conferences | Positive | +4.7% | Executives scheduled to present at major June healthcare conferences. |
| Jun 01 | Market making deal | Neutral | -4.2% | Renewal and amendment of Islandsbanki market making agreement. |
| May 11 | FDA inspection update | Positive | +10.1% | Completion of FDA surveillance inspection with addressable Form 483 observations. |
24h Move is the share-price change in the day after each event; other market factors may also have contributed.
Recent operational and regulatory updates have often coincided with positive single-day moves, with only one neutral agreement linked to a negative reaction.
Over the last six months, Alvotech has reported several regulatory and corporate milestones. On May 11, 2026, it completed an FDA cGMP surveillance inspection, with shares rising afterward. Early June 2026 brought an investor conference schedule, AGM approvals, and BLA resubmissions for AVT05 and AVT06, each linked to notable positive price reactions. A renewed market making agreement on June 1, 2026 was followed by a modest decline. Today’s BLA acceptance for AVT16 fits the pattern of frequent regulatory updates around its biosimilar pipeline.
Key Terms
biologics license application regulatory
biosimilar medical
interchangeable biosimilar medical
pharmacokinetic medical
immunogenicity medical
lyophilized medical
intravenous administration medical
crohn’s disease medical
AI-generated analysis. How Rhea-AI works. Not financial advice.
REYKJAVIK, Iceland, June 08, 2026 (GLOBE NEWSWIRE) -- Alvotech (NASDAQ: ALVO; ALVO-SDB), a global biotechnology company specializing in the development and manufacture of biosimilar medicines for patients worldwide, today announced that the U.S. Food and Drug Administration (FDA) has accepted for review a Biologics License Application (BLA) for AVT16, a proposed interchangeable biosimilar to Entyvio® (vedolizumab) lyophilized vial for intravenous administration.
Under a partnership with Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA), Alvotech is responsible for development and manufacturing of AVT16, while Teva is responsible for commercialization.
“FDA acceptance of the BLA for AVT16 is another important step in advancing our mission to increase access to biologic medicines for patients worldwide,” said Joseph McClellan, Chief Operating Officer of Alvotech. “Our proposed interchangeable biosimilar to Entyvio builds on our experience in immunology and reflects the strength of our fully integrated development and manufacturing platform.”
Entyvio is a biologic medicine approved for the treatment of adults with moderately to severely active ulcerative colitis and Crohn’s disease.
AVT16 is among Alvotech’s disclosed biosimilar candidates in immunology and form part of the company’s broader pipeline of biosimilar candidates aimed at expanding access to biologic medicines in major therapeutic areas.
The BLA submission is supported by a comprehensive data package, including analytical, pharmacokinetic, and immunogenicity data generated to support the demonstration of biosimilarity between AVT16 and the reference product.
AVT16 has been submitted as a proposed interchangeable biosimilar. In the United States, an interchangeable biosimilar may be substituted for the reference product at the pharmacy without the intervention of the prescriber, subject to applicable laws. If approved, AVT16 would add to the range of biosimilar options available to patients and healthcare providers in the United States.
In February 2026, Alvotech announced positive results from a pivotal pharmacokinetic study for AVT80, a proposed biosimilar to Entyvio for subcutaneous administration. The randomized, double-blind, single-dose, parallel-group, three-arm study compared AVT80 to Entyvio in healthy adult participants and met all its primary endpoints. Based on regulatory advice, the clinical study is considered pivotal to support the demonstration of clinical similarity for both AVT16 and AVT80.
About AVT16
AVT16 is a proposed interchangeable biosimilar candidate to Entyvio® (vedolizumab), a humanized monoclonal antibody. AVT16 is being developed as a lyophilized vial for intravenous administration. In the European Union, the European Medicines Agency has validated a Marketing Authorization Application covering both AVT16 (lyophilized vial) and AVT80 (pre-filled syringe and auto-injector). AVT16 and AVT80 are investigational products and have not received regulatory approval in any markets.
Biosimilarity and interchangeability have not been established by regulatory authorities and are not claimed.
About Entyvio®
Entyvio® (vedolizumab) is an integrin receptor antagonist indicated for the treatment of adults with moderately to severely active ulcerative colitis and Crohn’s disease. Vedolizumab targets and binds specifically to the alpha-4-beta-7 integrin, which is involved in the migration of certain white blood cells into gastrointestinal tissue.
Use of trademarks
Entyvio® is a registered trademark of Millennium Pharmaceuticals, Inc. The use of this trademark is solely for the purpose of identifying the reference product. Alvotech and Teva do not claim any rights to the trademark.
For further information, contact:
Media
Benedikt Stefansson
Sarah MacLeod
alvotech.media@alvotech.com
Investors
Dr. Balaji V Prasad
Benedikt Stefansson
alvotech.ir@alvotech.com
About Alvotech
Alvotech is a biotechnology company, founded by Robert Wessman, focused solely on the development and manufacture of biosimilar medicines for patients worldwide. Alvotech seeks to be a global leader in biosimilars by delivering high-quality, cost-effective products and services, enabled by a fully integrated approach and broad in-house capabilities. Five biosimilars are already approved and marketed in multiple global markets, including biosimilars to Humira® (adalimumab), Stelara® (ustekinumab), Simponi® (golimumab), Eylea® (aflibercept) and Prolia®/Xgeva® (denosumab). The current development pipeline includes nine disclosed biosimilar candidates aimed at treating autoimmune disorders, eye disorders, osteoporosis, respiratory disease, and cancer. Alvotech has formed a network of strategic commercial partnerships to provide global reach and leverage local expertise in markets that include the United States, Europe, Japan, China, and other Asian countries and large parts of South America, Africa and the Middle East. For more information, please visit https://www.alvotech.com. None of the information on the Alvotech website shall be deemed part of this press release.
For more information, please visit our investor portal, and our website or follow us on social media on LinkedIn, Facebook, Instagram and YouTube.
Alvotech Forward Looking Statements
Certain statements in this communication may be considered “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995, as amended. Forward-looking statements include, for example, Alvotech’s expectations regarding competitive advantages, business prospects and opportunities including pipeline product development, future plans and intentions, regulatory submissions, review and interactions, the potential approval and commercial launch of its product candidates, the timing of regulatory approval, market launches and financial projections. Such forward-looking statements are subject to risks, uncertainties, and other factors which could cause actual results to differ materially from those expressed or implied by such forward-looking statements. These forward-looking statements are based upon estimates and assumptions that, while considered reasonable by Alvotech and its management, are inherently uncertain and are inherently subject to risks, variability, and contingencies, many of which are beyond Alvotech’s control. Factors that may cause actual results to differ materially from current expectations include, but are not limited to factors set forth in the sections entitled “Risk Factors” and “Cautionary Note Regarding Forward-Looking Statements” in documents that Alvotech may from time-to-time file or furnish with the SEC. There may be additional risks that Alvotech does not presently know or that Alvotech currently believes are immaterial that could also cause actual results to differ from those contained in the forward-looking statements. These forward-looking statements are provided for illustrative purposes only and are not intended to serve as, and must not be relied on by an investor as, a guarantee, assurance, prediction or definitive statement of a fact or probability. Alvotech does not undertake any duty to update these forward-looking statements or to inform the recipient of any matters of which any of them becomes aware of which may affect any matter referred to in this communication. Alvotech disclaims any and all liability for any loss or damage (whether foreseeable or not) suffered or incurred by any person or entity as a result of anything contained or omitted from this communication and such liability is expressly disclaimed.
