Alvotech shares jump after FDA accepts Entyvio biosimilar application for review (ALVO)

Fiona Craig

Mon, June 8, 2026 astatine 5:41 AM CDT 1 min read

Alvotech (NASDAQ:ALVO) shares climbed 12% successful premarket trading connected Thursday aft the biotechnology institution announced that the U.S. Food and Drug Administration has accepted its Biologics License Application for AVT16, an interchangeable biosimilar campaigner to Entyvio.

The regulatory improvement represents an important measurement guardant for Alvotech arsenic it advances plans to vie successful the marketplace for biosimilar versions of the inflammatory bowel illness treatment.

FDA reappraisal advances AVT16 toward imaginable support

According to the company, AVT16 is being developed arsenic an interchangeable biosimilar to Entyvio, a biologic medicine wide utilized to dainty inflammatory bowel diseases.

FDA acceptance of the exertion means the bureau volition present proceed with a ceremonial reappraisal of the product, moving Alvotech person to a imaginable commercialized motorboat successful the United States.

The Iceland-based biopharmaceutical radical said that, if approved, AVT16 could beryllium substituted for Entyvio astatine pharmacies without prescriber intervention.

Interchangeable presumption could broaden marketplace accidental

An interchangeable biosimilar designation carries important commercialized advantages successful the U.S. market, arsenic it allows pharmacists to regenerate the notation merchandise with the biosimilar without requiring support from the prescribing physician.

Such a designation could assistance accelerate adoption of AVT16 and amended diligent entree portion creating a larger marketplace accidental for Alvotech.

The FDA’s determination to judge the exertion marks a cardinal regulatory milestone arsenic the institution continues to grow its biosimilars portfolio and prosecute further maturation opportunities successful large planetary healthcare markets.

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