Alvotech nine-month revenue falls 23% as FDA accepts AVT80 filing and clears Simlandi process
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.
Why it matters
- 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 ↗
Written by CompePharma's editorial system from the company's filing; claims are the company's. AI-assisted; check the source before acting. Not investment advice.
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