Alvotech sales slide by almost a quarter as FDA takes up Entyvio biosimilar filing
The Icelandic biosimilar maker booked about $97M less revenue in the first nine months of 2026 than a year earlier, while advancing regulatory milestones in the US and Europe.
Alvotech's adjusted revenue for the nine months to 30 September 2026 was $323.4M, down from $420.0M in the same period of 2025, a drop of roughly 23%. The company reported the figures on 11 November. It had $61.5M in cash at the end of September. The information available does not explain what drove the decline.
Alvotech is keeping its full-year revenue guidance of $650–700M but now expects to finish in the lower part of that band. Simple arithmetic shows the scale of the task: reaching $650M would require about $327M in the final quarter, roughly as much as the previous nine months combined. That calculation is ours and assumes guidance is set on the same adjusted basis as the nine-month figure, which the company's summary does not confirm.
On the pipeline, the US Food and Drug Administration has accepted Alvotech's biologics licence application for AVT80, a proposed biosimilar to Takeda's Entyvio (vedolizumab). Acceptance means the agency will begin a full review; it is not an approval, and no review timeline was provided.
The FDA has also approved a new manufacturing process for Simlandi, Alvotech's adalimumab biosimilar, along with a second drug substance suite at the company's Reykjavik facility. Separately, Alvotech has filed with the European Medicines Agency for a proposed biosimilar to Eylea HD, with no decision date disclosed.
Why it matters
- Revenue is down about $97M year on year over nine months, and management now points to the lower half of its $650–700M full-year guidance.
- The FDA's acceptance of the AVT80 filing starts formal review of a proposed Entyvio biosimilar, but approval and timing remain open.
- A cleared Simlandi process and a second drug substance suite in Reykjavik are manufacturing steps for an existing product; the effect on supply or costs was not quantified.
- The Eylea HD filing with the EMA adds a European ophthalmology biosimilar to the pipeline, with no decision timeline given.
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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