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Alvotech nine-month revenue falls 23% as FDA accepts AVT80 filing and clears Simlandi process

Alvotech (ALVO) · Thu 12 Nov 2026

The Icelandic biosimilar maker reported adjusted revenue of $323.4M for the first nine months of 2026 and now expects full-year results toward the lower end of guidance.

Alvotech reported nine-month results on 11 November 2026, with adjusted revenue of $323.4M, down from $420.0M in the same period a year earlier, a fall of about 23%. Adjusted EBITDA was $78.3M and cash stood at $61.5M.

On the regulatory side, the company said the US Food and Drug Administration has accepted its biologics licence application (BLA) for AVT80, a proposed biosimilar to vedolizumab. Alvotech also said the agency has approved a higher-output manufacturing process for Simlandi, its adalimumab biosimilar.

Manufacturing capacity also featured. Alvotech cited a second drug substance suite at its Reykjavik site. It further said it has made a submission to the European Medicines Agency (EMA) for a proposed biosimilar to Eylea HD (aflibercept 8 mg).

Alvotech maintained its full-year revenue guidance of $650M to $700M. It now expects results toward the lower end of that range. The summary available does not give reasons for the revenue decline or timelines for the regulatory reviews.

What it means for your team

  • Regulatory teams tracking biosimilars should note the FDA's acceptance of the AVT80 (vedolizumab) BLA; review timelines were not given in the information available.
  • The EMA submission for an aflibercept 8 mg biosimilar adds to the pipeline of proposed Eylea HD copies in Europe.
  • Quality and supply teams may note the FDA-approved higher-output Simlandi process and the additional Reykjavik drug substance suite, which bear on manufacturing capacity.
  • Market-access teams should factor in that Alvotech now expects revenue toward the low end of its $650-700M guidance.

Company's press release (SEC filing): Alvotech ↗

Article written by VigiEye from the official source (Alvotech). Claims are the company's own. AI-assisted; check the source before acting.

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