Key Highlights

  • ALVO shares rose 5.96% today to $5.25, up from a previous close of $4.95.
  • The FDA accepted for review Alvotech's Biologics License Application for AVT80, a proposed interchangeable biosimilar to Entyvio.
  • AVT80 is being developed for subcutaneous administration via prefilled syringe and autoinjector.
  • The company's AVT16 intravenous biosimilar candidate for the same reference product had its BLA accepted in May 2026.
  • Market Capitalization reached approximately 1.77 billion dollars following the move.

FDA Acceptance Expands Entyvio Biosimilar Program

Alvotech (NASDAQ:ALVO) shares rose 5.96% today to $5.25 after the company announced that the U.S. Food and Drug Administration accepted for review a Biologics License Application for AVT80, a proposed interchangeable biosimilar to Entyvio in prefilled syringe and autoinjector form for subcutaneous administration.

Alvotech is a Luxembourg-headquartered biosimilar developer with major operations in Reykjavik, Iceland, focused on Manufacturing biosimilar medicines across autoimmune, inflammatory, ophthalmic, and oncology indications. The company already markets several approved biosimilars, including versions of Humira, Stelara, Simponi, Eylea, and Prolia/Xgeva.

AVT80 is being developed under a Partnership with Teva Pharmaceutical Industries, with Alvotech responsible for development and manufacturing and Teva handling commercialization. The submission is supported by analytical, pharmacokinetic, and immunogenicity data intended to establish biosimilarity with the reference product. If approved as interchangeable, AVT80 could be substituted for Entyvio at the pharmacy level without prescriber intervention, subject to applicable state laws.

Momentum Builds Alongside Other Recent Catalysts

The AVT80 news follows the May 2026 FDA acceptance of Alvotech's BLA for AVT16, the intravenous formulation of the same vedolizumab biosimilar, meaning the company's Entyvio biosimilar program now spans both administration routes. The European Medicines Agency has also validated a Marketing authorization application covering both candidates.

Alvotech's market capitalization stands at approximately 1.77 billion dollars, with shares trading in a 52-week range of $2.94 to $9.25. The stock has risen sharply over the past month, a trend the company has attributed to a combination of regulatory progress, a separate biosimilar licensing agreement, and a positive rating initiation from a research firm.

What Comes Next for Alvotech

With both intravenous and subcutaneous biosimilar candidates for Entyvio now under FDA review, Alvotech's near-term catalysts center on regulatory timelines and the eventual commercial rollout led by Teva. Investors will watch for further updates on the BLA review process and any additional biosimilarity data disclosures as the program advances.