FDA to review Alvotech (Nasdaq: ALVO) subcutaneous Entyvio biosimilar
Rhea-AI Filing Summary
Alvotech (ALVO) reports that the U.S. FDA has accepted for review a Biologics License Application (BLA) for AVT80, a proposed interchangeable biosimilar to Entyvio (vedolizumab) in prefilled syringe and autoinjector formats for subcutaneous use. Under its partnership with Teva, Alvotech leads development and manufacturing while Teva handles commercialization.
The BLA is supported by analytical, pharmacokinetic and immunogenicity data, including a randomized, double-blind, single-dose, three-arm pivotal study that met all primary endpoints. AVT80 complements AVT16, Alvotech’s proposed intravenous Entyvio biosimilar, for which the FDA accepted a BLA in May 2026, creating a two-presentation vedolizumab biosimilar program within Alvotech’s broader immunology pipeline. Both AVT16 and AVT80 remain investigational; no regulatory approvals have been granted and biosimilarity or interchangeability is not yet established.
Positive
- FDA acceptance of BLA for AVT80 advances U.S. vedolizumab biosimilar program, adding a proposed interchangeable subcutaneous option alongside AVT16 intravenous and potentially broadening Alvotech’s immunology portfolio if regulatory reviews conclude favorably.
Negative
- None.
Key Figures
BLA acceptance date for AVT80: August 31, 2026
AVT16 BLA acceptance month: May 2026
Pivotal study design arms: three-arm
+2 more
5 metrics
BLA acceptance date for AVT80
August 31, 2026
FDA acceptance for review of the Biologics License Application for AVT80
AVT16 BLA acceptance month
May 2026
FDA accepted BLA for AVT16, the intravenous vedolizumab biosimilar candidate
Pivotal study design arms
three-arm
Randomized, double-blind, single-dose, parallel-group pivotal study comparing AVT80 to Entyvio
Number of approved biosimilars
Five biosimilars
Biosimilars already approved and marketed in multiple global markets
EU MAA validation
Both AVT16 and AVT80
European Medicines Agency validated a Marketing Authorization Application covering both candidates
Key Terms
Biologics License Application, interchangeable biosimilar, pharmacokinetic, immunogenicity, +1 more
5 terms
Biologics License Application regulatory
"FDA has accepted for review a Biologics License Application (BLA) for AVT80"
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.
interchangeable biosimilar regulatory
"AVT80, a proposed interchangeable biosimilar to Entyvio"
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.
Marketing Authorization Application regulatory
"the European Medicines Agency has validated a Marketing Authorization Application"
A marketing authorization application is a formal request submitted to a government regulator asking permission to sell a prescription medicine or medical product in a country or region. Think of it like asking for a business license after showing evidence the product is safe and works; investors care because approval determines whether the product can generate sales, how soon revenue starts, and how much regulatory risk and uncertainty remains.
FAQ
What did Alvotech (ALVO) announce regarding AVT80 in this 6-K?
Alvotech announced that the U.S. FDA has accepted for review a Biologics License Application for AVT80, a proposed interchangeable biosimilar to Entyvio (vedolizumab) prefilled syringe and autoinjector for subcutaneous administration.
How are Alvotech and Teva collaborating on AVT80?
Under the partnership, Alvotech is responsible for development and manufacturing of AVT80, while Teva is responsible for commercialization, combining Alvotech’s biosimilar capabilities with Teva’s commercial infrastructure.
What supports the AVT80 BLA according to Alvotech (ALVO)?
The AVT80 BLA is supported by a comprehensive data package, including analytical, pharmacokinetic and immunogenicity data, plus a randomized, double-blind, single-dose, parallel-group, three-arm pivotal study that compared AVT80 to Entyvio and met all primary endpoints.
How does AVT80 relate to Alvotech’s AVT16 biosimilar candidate?
AVT80 is a proposed interchangeable subcutaneous Entyvio biosimilar, complementing AVT16, Alvotech’s proposed interchangeable intravenous Entyvio biosimilar. The FDA accepted AVT16’s BLA for review in May 2026, and together they cover both IV and SC presentations.
Has AVT80 or AVT16 been approved by regulators yet?
No. Alvotech states that AVT16 and AVT80 are investigational products and have not received regulatory approval in any market. Biosimilarity and interchangeability have not been established by regulatory authorities and are not claimed.
What other biosimilars does Alvotech (ALVO) already market?
Alvotech reports that five biosimilars are already approved and marketed globally, including biosimilars to Humira, Stelara, Simponi, Eylea and Prolia/Xgeva, alongside a pipeline targeting autoimmune disorders, eye disorders and cancer.
AI-generated analysis. How Rhea-AI works. Not financial advice.
