Alvotech announces FDA acceptance of Biologics License Application for AVT16, a proposed interchangeable biosimilar to Entyvio®

Alvotech (NASDAQ: ALVO) announced FDA acceptance for review of its Biologics License Application for AVT16, a proposed interchangeable biosimilar to Entyvio (vedolizumab) IV.

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.

Argus Jun 8 session

+19.77% close to close Open Argus

Details

News Market Reaction – ALVO

On Jun 8, the day this news came out, ALVO closed 19.77% above the previous close.

Data tracked by StockTitan Argus for the Jun 8 session.

Market Context

On Jun 8, the day this news came out, the stock closed 19.8% above the previous close. A strong posi...

Analysis

On Jun 8, the day this news came out, the stock closed 19.8% above the previous close. A strong positive reaction aligns with Alvotech’s history of favorable responses to regulatory milestones, such as prior BLA resubmissions and inspection updates. FDA acceptance of the AVT16 BLA expands its immunology biosimilar pipeline alongside AVT80 and other assets. However, shares still traded well below the $11.12 52-week high and the 200-day MA at $5.34, underscoring execution, financing, and regulatory risks already highlighted in recent filings.

Key Figures

Net profit: $27.9 million Accumulated deficit: $2,409.8 million 2025 revenue outlook: $570–$600 million +5 more

Net profit

$27.9 million

Year ended Dec 31, 2025 (Form 20-F)

Accumulated deficit

$2,409.8 million

As of Dec 31, 2025 (Form 20-F)

2025 revenue outlook

$570–$600 million

Total revenue guidance for 2025 (Dec 17, 2025 6-K)

2025 adj. EBITDA outlook

$130–$150 million

Adjusted EBITDA guidance for 2025 (Dec 17, 2025 6-K)

2026 revenue target

$650–$700 million

Total revenue target for 2026 (Dec 17, 2025 6-K)

2026 adj. EBITDA target

$180–$220 million

Adjusted EBITDA target for 2026 (Dec 17, 2025 6-K)

Convertible bonds issued

$108 million

Senior unsecured convertible bonds due 2030 (Dec 17, 2025 6-K)

Convertible coupon

6.875%

Coupon on 2030 senior unsecured convertible bonds

Historical Context

5 past events · Latest: Jun 04

5 events

1. Jun 04

   BLA resubmissions

   24h Move

   +19.1%

   Resubmission of AVT05 and AVT06 BLAs after addressing FDA feedback.

2. Jun 03

   AGM outcomes

   24h Move

   +19.1%

   All resolutions approved at 2026 AGM and EGM in Luxembourg.

3. Jun 02

   Investor conferences

   24h Move

   +4.7%

   Executives scheduled to present at major June healthcare conferences.

4. Jun 01

   Market making deal

   24h Move

   -4.2%

   Renewal and amendment of Islandsbanki market making agreement.

5. May 11

   FDA inspection update

   24h Move

   +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.

Key Terms

biologics license application, biosimilar, interchangeable biosimilar, pharmacokinetic, +4 more

8 terms

biologics license application regulatory

"FDA has accepted for review a Biologics License Application (BLA) for AVT16"

A biologics license application is a formal request submitted to regulatory authorities seeking approval to market a new biological medicine, such as vaccines or treatments made from living organisms. It is a comprehensive review process that evaluates the safety, effectiveness, and manufacturing quality of the product. For investors, receiving approval signals that a biological therapy can be sold to the public, potentially leading to revenue growth and market success.

biosimilar medical

"AVT16, a proposed interchangeable biosimilar to Entyvio"

A biosimilar is a medicine created to be highly similar to an existing complex drug made from living cells, matching its safety and effectiveness while allowing for small, natural variations. For investors, biosimilars matter because they introduce lower-cost competition when patents end, which can cut prices, shift market share, and change revenue forecasts for companies selling the original drugs, much like a generic version does for simpler chemical medicines.

interchangeable biosimilar medical

"AVT16 has been submitted as a proposed interchangeable biosimilar"

An interchangeable biosimilar is a version of a complex biological medicine that regulators have judged to be so similar to the original product that it can be substituted at the pharmacy without a new prescription. For investors, interchangeability matters because it usually speeds patient access and enables automatic substitution, which can sharply increase market share for the cheaper product and put pricing pressure on the original drug, affecting future revenues and margins.

pharmacokinetic medical

"including analytical, pharmacokinetic, and immunogenicity data generated"

Pharmacokinetic describes how a drug moves through and leaves the body — how it is absorbed, spread to tissues, broken down and excreted — like tracking a package from pickup to delivery and disposal. For investors, these properties determine effective dose, safety risks, how often a medicine must be taken, and how reliably it works, which in turn influence clinical trial success, regulatory approval chances, production complexity and a drug’s commercial value.

immunogenicity medical

"including analytical, pharmacokinetic, and immunogenicity data generated"

Immunogenicity is the ability of a substance, such as a vaccine or medication, to provoke an immune response in the body. It matters to investors because high immunogenicity can affect the effectiveness and safety of a product, potentially leading to increased costs or regulatory challenges. Understanding immunogenicity helps assess the long-term viability and market potential of pharmaceutical and biotech investments.

lyophilized medical

"vedolizumab) lyophilized vial for intravenous administration"

Lyophilized means a drug, vaccine, or biological product has been freeze-dried: water is removed by freezing the item and then turning the ice into vapor to leave a dry, stable powder. For investors, lyophilization matters because it improves shelf life, eases shipping and storage without refrigeration, and can affect manufacturing cost, regulatory approval paths, and commercial reach—much like how freeze-dried coffee or fruit lasts longer and travels better than fresh.

intravenous administration medical

"lyophilized vial for intravenous administration"

Intravenous administration is delivering a drug or fluid directly into a vein using a needle or tube, so the substance enters the bloodstream immediately. For investors, it matters because this route gives faster, more predictable effects and often higher costs, special equipment or clinical procedures, which can affect a therapy’s safety profile, regulatory approval path, pricing, and how easily it can be used outside hospitals — all factors that influence market potential.

crohn’s disease medical

"approved for the treatment of adults with moderately to severely active ulcerative colitis and Crohn’s disease"

A long-lasting inflammatory condition that can inflame any part of the digestive tract, causing pain, diarrhea, weight loss and fatigue; symptoms often flare up unpredictably and may require lifelong medication or surgery. Investors monitor Crohn’s disease because its chronic, costly nature creates steady demand for treatments, diagnostics and medical services, so new drugs, trial results or approval decisions can materially change sales prospects and company valuations — think of it like a recurring plumbing problem that drives ongoing repair business.

AI-generated analysis. How Rhea-AI works. Not financial advice.

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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.

FAQ

AI-generated questions and answers. How Rhea-AI works. Not financial advice.

What did Alvotech (NASDAQ: ALVO) announce about the FDA review of AVT16 in June 2026?

Alvotech announced that the FDA accepted for review its Biologics License Application for AVT16, a proposed interchangeable biosimilar to Entyvio. According to Alvotech, the application covers the lyophilized vial for intravenous use in adults with ulcerative colitis and Crohn’s disease.

What is AVT16, Alvotech’s proposed interchangeable biosimilar to Entyvio (ALVO)?

AVT16 is a proposed interchangeable biosimilar to Entyvio (vedolizumab) in lyophilized vial form for intravenous administration. According to Alvotech, it is intended for adults with moderately to severely active ulcerative colitis and Crohn’s disease, potentially broadening biosimilar treatment options if approved.

How are Alvotech and Teva collaborating on AVT16, the Entyvio biosimilar (ALVO, TEVA)?

Alvotech and Teva have a partnership where Alvotech develops and manufactures AVT16, while Teva is responsible for commercialization. According to Alvotech, this fully integrated model combines its biosimilar development platform with Teva’s commercial infrastructure to support future U.S. market entry, subject to FDA approval.

What data support the Biologics License Application for AVT16 filed by Alvotech (ALVO)?

The AVT16 BLA is supported by analytical, pharmacokinetic and immunogenicity data comparing it with reference Entyvio. According to Alvotech, this comprehensive package is designed to support the demonstration of biosimilarity and the proposed interchangeable designation under U.S. regulatory standards for biosimilar products.

How does the AVT80 pharmacokinetic study relate to Alvotech’s AVT16 and AVT80 biosimilars?

A pivotal pharmacokinetic study of AVT80, a proposed subcutaneous biosimilar to Entyvio, met all primary endpoints. According to Alvotech, regulators consider this randomized, double-blind study pivotal to support clinical similarity for both AVT16 and AVT80, strengthening the company’s Entyvio biosimilar program.

What could FDA approval of AVT16 mean for biosimilar options to Entyvio in the United States?

If the FDA approves AVT16, it could add another biosimilar option to reference Entyvio for U.S. patients. According to Alvotech, AVT16 is filed as a proposed interchangeable biosimilar, which may allow pharmacy-level substitution where permitted under applicable state and federal laws.